GELFOAM
Report
- Report Number
- 1810189-2021-00004
- Event Type
- Injury
- Date Received
- February 19, 2021
- Report Date
- February 9, 2021
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
SEVERITY OF HARM WAS S4. SITE SAMPLE STATUS WAS NOT RECEIVED. PGS SAFETY SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. (PARENT) PRODUCT-DESCRIPTION: GELFOAM-JMI POWDER KIT 5000 IU. INVESTIGATION DECISION: FPRS EVALUATION COMMENT: PFIZER SAFETY SITE AGREES WITH THE INVESTIGATION DECISION, CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, AND JUSTIFICATION. SITE ASSIGNMENT TABLE WAS REVIEWED AND IS ACCURATE AND APPROPRIATE. AN INVESTIGATION WILL BE PERFORMED. NO REPEAT INVESTIGATION. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION WAS H03-04, FUNCTIONALITY - CRITICAL PERFORMANCE (INX100401277V1.0), AND THE WORST CASE SEVERITY WAS S4. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REQUIRING ESCALATION. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. MALFUNCTION IS NOT PRESENT IN THIS CASE (OFF-LABEL USE). NOTIFICATION WAS MADE TO THE DCHU OF PREVIOUS MDR FOR SIMILAR CASES. THIS IS A COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM JMI. THE INITIAL SCOPE ALL BATCHES PRODUCED WITHIN 24 MONTHS PRIOR TO RECEIPT OF THE REPORTED COMPLAINT AS THAT TIMEFRAME WILL CAPTURE ANY BATCHES WITHIN EXPIRY ON THE MARKET. THE COMPLAINT WILL INCLUDE REVIEW OF ANY PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS DETERMINED TO BE WITHIN SCOPE. THIS IS NOT PROCESS RELATED AND FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. ROOT CAUSE: PFIZER SAFETY SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SAFETY SITE PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SAFETY SITE. IMPACT ANALYSIS: QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO SAFETY SITE CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIONS, CORRECTIVE AND PREVENTATIVE ACTIONS: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS A REVIEW OF PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS FOR THE RELEVANT PRODUCT CLASS, SUB-CLASS RECEIVED WITHIN 36 MONTHS (THE LARGER EXPIRY INTERVAL OF THE PRODUCTS FOR GELFOAM) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. THE REQUIRED MINIMUM OF 5 DATA POINTS WAS CAPTURED; HOWEVER, OF ALL PREVIOUS INVESTIGATIONS, THERE WERE NONE WITH A KNOWN BATCH NUMBER FOR EITHER IMPLICATED PRODUCT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. INVESTIGATION: OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. THE SCOPE WAS NOT EXPANDED AS A RESULT OF INVESTIGATION. DOCUMENT REVIEW SUMMARY: DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. APRR REVIEW: COMPLETE - ACCEPTABLE. A REVIEW OF APRR FOR THE PRODUCTS AND TIMEFRAME IN SCOPE DID NOT FIND ANY ISSUE RELATED TO THE REPORTED COMPLAINT. QO BATCH HISTORY REPORT: A REVIEW OF RELEASE TESTING RESULTS COULD NOT BE PERFORMED AS THE REPORTED COMPLAINT BATCH IS UNKNOWN. RESERVE SAMPLE EVALUATION: VISUAL RESRV SAMPLE EVAL DESC.: BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION, ADDITIONALLY, THERE WERE NO COMPLAINTS WITH A KNOWN BATCH NUMBER DETERMINED TO BE WITHIN SCOPE FOR WHICH A PREVIOUS EXAMINATION OF RETAINED REFERENCE SAMPLES COULD BE REVIEWED. NO LOT-SPECIFIC TREND IDENTIFIED. LOT TREND ASSMT. & RATIONALE: COMPLETE-ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. LOT TREND ACTIONS TAKEN: NO BATCH TRENDS WERE IDENTIFIED; THEREFORE, NO BATCH TREND ACTIONS WERE REQUIRED. NO EXPEDITE TREND IDENTIFIED. NO OTHER TREND IDENTIFIED. OTHER TREND ASSMT. & RATIONALE: MEDICAL DEVICE REPORT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT HAD BEEN ISSUED; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO DCHU FOR EVALUATION OF REPORTABILITY. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR PRODUCTS WITH THE PRODUCT CATEGORY DEFINED AS 'ABSORBABLE MATERIAL', 'DELIVERY SYSTEM' AND 'TOPICAL' HAS BEEN REVIEWED. THE FOLLOWING PARAMETERS WERE USED: -PRODUCT CATEGORY: ABSORBABLE MATERIAL, DELIVERY SYSTEM, TOPICAL -TIME PERIOD: 23FEB2018 - 23FEB2021 -COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION -INVESTIGATING SITE: PFIZER KDP THE PRODUCT CATEGORY OF 'TOPICAL' WAS USED TO CAPTURE ANY OVERLAP IN COMPLAINTS INVOLVING THROMBIN NOT CAPTURED BY THE CATEGORIES 'ABSORBABLE MATERIAL' OR 'DELIVERY SYSTEM'. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (JANUARY 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. MEDICAL DEVICE COMPONENT TREND: A REVIEW OF TRENDS FOR MEDICAL DEVICE CONSTITUENTS FOR THE REPORTED PRODUCT COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN.
SEVERITY OF HARM WAS S4. SITE SAMPLE STATUS WAS NOT RECEIVED. PGS SAFETY SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. (PARENT) PRODUCT-DESCRIPTION: GELFOAM-JMI POWDER KIT 5000 IU. INVESTIGATION DECISION: FPRS EVALUATION COMMENT: PFIZER SAFETY SITE AGREES WITH THE INVESTIGATION DECISION, CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, AND JUSTIFICATION. SITE ASSIGNMENT TABLE WAS REVIEWED AND IS ACCURATE AND APPROPRIATE. AN INVESTIGATION WILL BE PERFORMED. NO REPEAT INVESTIGATION. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION WAS H03-04, FUNCTIONALITY - CRITICAL PERFORMANCE (INX100401277V1.0), AND THE WORST CASE SEVERITY WAS S4. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REQUIRING ESCALATION. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. MALFUNCTION IS NOT PRESENT IN THIS CASE (OFF-LABEL USE). NOTIFICATION WAS MADE TO THE DCHU OF PREVIOUS MDR FOR SIMILAR CASES. THIS IS A COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM JMI. THE INITIAL SCOPE ALL BATCHES PRODUCED WITHIN 24 MONTHS PRIOR TO RECEIPT OF THE REPORTED COMPLAINT AS THAT TIMEFRAME WILL CAPTURE ANY BATCHES WITHIN EXPIRY ON THE MARKET. THE COMPLAINT WILL INCLUDE REVIEW OF ANY PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS DETERMINED TO BE WITHIN SCOPE. THIS IS NOT PROCESS RELATED AND FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. ROOT CAUSE: PFIZER SAFETY SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SAFETY SITE PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SAFETY SITE. IMPACT ANALYSIS: QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO SAFETY SITE CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIONS, CORRECTIVE AND PREVENTATIVE ACTIONS: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS A REVIEW OF PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS FOR THE RELEVANT PRODUCT CLASS, SUB-CLASS RECEIVED WITHIN 36 MONTHS (THE LARGER EXPIRY INTERVAL OF THE PRODUCTS FOR GELFOAM) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. THE REQUIRED MINIMUM OF 5 DATA POINTS WAS CAPTURED; HOWEVER, OF ALL PREVIOUS INVESTIGATIONS, THERE WERE NONE WITH A KNOWN BATCH NUMBER FOR EITHER IMPLICATED PRODUCT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. INVESTIGATION: OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. THE SCOPE WAS NOT EXPANDED AS A RESULT OF INVESTIGATION. DOCUMENT REVIEW SUMMARY: DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. APRR REVIEW: COMPLETE - ACCEPTABLE. A REVIEW OF APRR FOR THE PRODUCTS AND TIMEFRAME IN SCOPE DID NOT FIND ANY ISSUE RELATED TO THE REPORTED COMPLAINT. QO BATCH HISTORY REPORT: A REVIEW OF RELEASE TESTING RESULTS COULD NOT BE PERFORMED AS THE REPORTED COMPLAINT BATCH IS UNKNOWN. RESERVE SAMPLE EVALUATION: VISUAL RESRV SAMPLE EVAL DESC.: BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION, ADDITIONALLY, THERE WERE NO COMPLAINTS WITH A KNOWN BATCH NUMBER DETERMINED TO BE WITHIN SCOPE FOR WHICH A PREVIOUS EXAMINATION OF RETAINED REFERENCE SAMPLES COULD BE REVIEWED. NO LOT-SPECIFIC TREND IDENTIFIED. LOT TREND ASSMT. & RATIONALE: COMPLETE-ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. LOT TREND ACTIONS TAKEN: NO BATCH TRENDS WERE IDENTIFIED; THEREFORE, NO BATCH TREND ACTIONS WERE REQUIRED. NO EXPEDITE TREND IDENTIFIED. NO OTHER TREND IDENTIFIED. OTHER TREND ASSMT. & RATIONALE: MEDICAL DEVICE REPORT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT HAD BEEN ISSUED; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO DCHU FOR EVALUATION OF REPORTABILITY. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR PRODUCTS WITH THE PRODUCT CATEGORY DEFINED AS 'ABSORBABLE MATERIAL', 'DELIVERY SYSTEM' AND 'TOPICAL' HAS BEEN REVIEWED. THE FOLLOWING PARAMETERS WERE USED: -PRODUCT CATEGORY: ABSORBABLE MATERIAL, DELIVERY SYSTEM, TOPICAL -TIME PERIOD: 23FEB2018 - 23FEB2021 -COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION -INVESTIGATING SITE: PFIZER KDP THE PRODUCT CATEGORY OF 'TOPICAL' WAS USED TO CAPTURE ANY OVERLAP IN COMPLAINTS INVOLVING THROMBIN NOT CAPTURED BY THE CATEGORIES 'ABSORBABLE MATERIAL' OR 'DELIVERY SYSTEM'. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH ((B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS ((B)(4)); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS ((B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS ((B)(4), RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. MEDICAL DEVICE COMPONENT TREND: A REVIEW OF TRENDS FOR MEDICAL DEVICE CONSTITUENTS FOR THE REPORTED PRODUCT COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN.
SEVERITY OF HARM WAS S4. SITE SAMPLE STATUS WAS NOT RECEIVED. PGS SAFETY SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. (PARENT) PRODUCT-DESCRIPTION: GELFOAM-JMI POWDER KIT 5000 IU. INVESTIGATION DECISION: FPRS EVALUATION COMMENT: PFIZER SAFETY SITE AGREES WITH THE INVESTIGATION DECISION, CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, AND JUSTIFICATION. SITE ASSIGNMENT TABLE WAS REVIEWED AND IS ACCURATE AND APPROPRIATE. AN INVESTIGATION WILL BE PERFORMED. NO REPEAT INVESTIGATION. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION WAS H03-04, FUNCTIONALITY - CRITICAL PERFORMANCE (INX100401277V1.0), AND THE WORST CASE SEVERITY WAS S4. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REQUIRING ESCALATION. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. MALFUNCTION IS NOT PRESENT IN THIS CASE (OFF-LABEL USE). NOTIFICATION WAS MADE TO THE DCHU OF PREVIOUS MDR FOR SIMILAR CASES. THIS IS A COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM JMI. THE INITIAL SCOPE ALL BATCHES PRODUCED WITHIN 24 MONTHS PRIOR TO RECEIPT OF THE REPORTED COMPLAINT AS THAT TIMEFRAME WILL CAPTURE ANY BATCHES WITHIN EXPIRY ON THE MARKET. THE COMPLAINT WILL INCLUDE REVIEW OF ANY PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS DETERMINED TO BE WITHIN SCOPE. THIS IS NOT PROCESS RELATED AND FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. ROOT CAUSE: PFIZER SAFETY SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SAFETY SITE PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SAFETY SITE. IMPACT ANALYSIS: QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO SAFETY SITE CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIONS, CORRECTIVE AND PREVENTATIVE ACTIONS: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS A REVIEW OF PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS FOR THE RELEVANT PRODUCT CLASS, SUB-CLASS RECEIVED WITHIN 36 MONTHS (THE LARGER EXPIRY INTERVAL OF THE PRODUCTS FOR GELFOAM) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. THE REQUIRED MINIMUM OF 5 DATA POINTS WAS CAPTURED; HOWEVER, OF ALL PREVIOUS INVESTIGATIONS, THERE WERE NONE WITH A KNOWN BATCH NUMBER FOR EITHER IMPLICATED PRODUCT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. INVESTIGATION: OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. THE SCOPE WAS NOT EXPANDED AS A RESULT OF INVESTIGATION. DOCUMENT REVIEW SUMMARY: DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. APRR REVIEW: COMPLETE - ACCEPTABLE. A REVIEW OF APRR FOR THE PRODUCTS AND TIMEFRAME IN SCOPE DID NOT FIND ANY ISSUE RELATED TO THE REPORTED COMPLAINT. QO BATCH HISTORY REPORT: A REVIEW OF RELEASE TESTING RESULTS COULD NOT BE PERFORMED AS THE REPORTED COMPLAINT BATCH IS UNKNOWN. RESERVE SAMPLE EVALUATION: VISUAL RESRV SAMPLE EVAL DESC.: BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION, ADDITIONALLY, THERE WERE NO COMPLAINTS WITH A KNOWN BATCH NUMBER DETERMINED TO BE WITHIN SCOPE FOR WHICH A PREVIOUS EXAMINATION OF RETAINED REFERENCE SAMPLES COULD BE REVIEWED. NO LOT-SPECIFIC TREND IDENTIFIED. LOT TREND ASSMT. & RATIONALE: COMPLETE-ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. LOT TREND ACTIONS TAKEN: NO BATCH TRENDS WERE IDENTIFIED; THEREFORE, NO BATCH TREND ACTIONS WERE REQUIRED. NO EXPEDITE TREND IDENTIFIED. NO OTHER TREND IDENTIFIED. OTHER TREND ASSMT. & RATIONALE: MEDICAL DEVICE REPORT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT HAD BEEN ISSUED; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO DCHU FOR EVALUATION OF REPORTABILITY. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR PRODUCTS WITH THE PRODUCT CATEGORY DEFINED AS 'ABSORBABLE MATERIAL', 'DELIVERY SYSTEM' AND 'TOPICAL' HAS BEEN REVIEWED. THE FOLLOWING PARAMETERS WERE USED: -PRODUCT CATEGORY: ABSORBABLE MATERIAL, DELIVERY SYSTEM, TOPICAL -TIME PERIOD: 23FEB2018 - 23FEB2021 -COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION -INVESTIGATING SITE: PFIZER KDP THE PRODUCT CATEGORY OF 'TOPICAL' WAS USED TO CAPTURE ANY OVERLAP IN COMPLAINTS INVOLVING THROMBIN NOT CAPTURED BY THE CATEGORIES 'ABSORBABLE MATERIAL' OR 'DELIVERY SYSTEM'. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (JANUARY 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. MEDICAL DEVICE COMPONENT TREND: A REVIEW OF TRENDS FOR MEDICAL DEVICE CONSTITUENTS FOR THE REPORTED PRODUCT COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN.
EVENT VERBATIM [PREFERRED TERM] ANAPHYLAXIS AFTER INJECTING A HEMOSTATIC AGENT CONTAINING GELATIN [ANAPHYLACTIC REACTION], , NARRATIVE: THIS IS A LITERATURE REPORT FROM SPINE DEFORMITY, 2021, (DOI: 10.1007/S43390-020-00273-4) ENTITLED, 'ANAPHYLAXIS AFTER INJECTING A HEMOSTATIC AGENT CONTAINING GELATIN INTO VERTEBRAL BONE UNDER PRESSURE-A WARNING.' CASE 1: A 7 1/2-YEAR-OLD BOY WITH CONGENITAL SCOLIOSIS AND SURGICALLY CORRECTED TETRALOGY OF FALLOT UNDERWENT HEMIVERTEBRA RESECTION AND POSTERIOR SPINAL INSTRUMENTATION WITH FUSION. DOCUMENTED ALLERGIES INCLUDED VERSED AND FENTANYL, WHICH CAUSED TACHYCARDIA AND CHEST PAIN. AT THE TIME OF SURGERY IN THE PRONE POSITION, T7-T10 WAS EXPOSED BILATERALLY. TOPICAL GELFOAM POWDER WITH THROMBIN WAS USED FOR HEMOSTASIS. AFTER THE LEFT T9 PEDICLE WAS ISOLATED, THE VERTEBRAL BODY WAS CANNULATED, AND SEVERAL MILLILITERS OF BOVINE-DERIVED HEMOSTATIC AGENT WERE INJECTED INTRAOSSEOUS UNDER MANUAL PRESSURE THROUGH A SYRINGE. APPROXIMATELY 10 MIN LATER, A TRANSIENT DECREASED BLOOD PRESSURE WAS NOTED AS WELL AS INCREASED END-TIDAL CO2 LEVELS. TWENTY MINUTES LATER, HEMODYNAMIC INSTABILITY WORSENED, THE HEART RATE WAS LOST AND THE VENTILATION BECAME MORE DIFFICULT. THE INCISION WAS RAPIDLY CLOSED, THE PATIENT THEN TRANSFERRED TO A BED IN THE SUPINE POSITION AND 20 MIN OF FULL CARDIAC RESUSCITATION AND CHEST COMPRESSIONS WAS PERFORMED BEFORE SPONTANEOUS CIRCULATION RETURNED. AN ECHOCARDIOGRAM OBTAINED AFTER THE RETURN OF SPONTANEOUS CIRCULATION SHOWED NORMAL CARDIAC FUNCTION AND NO EVIDENCE OF AIR EMBOLISM. ONE HOUR AFTER THE INTRAOSSEOUS GELATIN INJECTION, A GENERALIZED URTICARIAL RASH WAS NOTED, ACCOMPANIED BY AREAS OF SKIN HYPOPERFUSION. TRYPTASE LEVEL OBTAINED WITHIN 2 H OF THE EVENT WAS 22.7 NG/ ML (NL < 11.5). GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THERE WAS NO FURTHER HEMODYNAMIC INSTABILITY OR RECURRENCE OF SYMPTOMS IN THE INITIAL POSTOPERATIVE PHASE OF HIS CARE. HE WAS SUCCESSFULLY EXTUBATED ON A POSTOPERATIVE DAY ONE WITH A RESOLUTION OF HIS RASH AND IMPROVEMENT IN HIS CARDIOPULMONARY STATUS. AN ALLERGY AND IMMUNOLOGY CONSULTANT RECOMMENDED PRE-MEDICATING HIM WITH PREDNISONE 24 MG TWICE DAILY, CETIRIZINE 5 MG TWICE DAILY AND RANITIDINE 75 MG TWICE DAILY FOR 48 H BEFORE RETURNING TO THE OPERATING ROOM. THE CONSULTANT ALSO RECOMMENDED THAT THE BEST WAY TO ASSESS ALLERGENS TO THESE MEDICATIONS WAS AFTER HE HAD BEEN OFF OF ANTIHISTAMINES FOR 7 DAYS. THE SURGERY WAS COMPLETED THE FOLLOWING WEEK, WITHOUT THE USE OF LIQUID GELATIN PRODUCTS AND HIS POSTOPERATIVE COURSE WAS OTHERWISE UNEVENTFUL. RADIO-ALLERGOSORBENT TESTING (RAST) SHOWED ELEVATED IGE LEVELS TO BOVINE GELATIN (7.1; NL < 3.5). DISCUSSION: THE AUTHORS PRESENT A CASE IN WHICH PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. ANAPHYLAXIS OCCURRED SHORTLY AFTER THE INJECTION OF HEMOSTATIC AGENTS INTO THE ENCLOSED SPACE OF THE VERTEBRAL BODY. THE CASES HAD CARDIOVASCULAR COLLAPSE, SKIN CHANGES, AND ELEVATED TRYPTASE LEVELS. CASE 1 HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA CAN BE USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS ARE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. THE RATE AT WHICH THESE MATERIALS DISSEMINATE FROM BONE IS RAPID, AS SHOWN BY THE PATIENT DESCRIBED IN THIS SERIES, WHO DEVELOPED ANAPHYLAXIS WITHIN MINUTES OF INJECTION INTO THE VERTEBRAL BODY. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS (REFERENCE).BOVINE THROMBIN MAY CAUSE HYPOTENSION AND EVEN DIC AT DOSES OF 60 U/KG (REFERENCE). THE PATIENT DEVELOPED HYPOTENSION, BRONCHOSPASM AND RASH, WITH A RAPID TEMPORAL RELATIONSHIP BETWEEN ADMINISTRATION OF THE MATERIAL AND THE ONSET OF SYMPTOMS.IN SUMMARY, THE AUTHORS DESCRIBE A CASE IN WHICH PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS INTO THE NON-EXPANDABLE CLOSED SPACE OF THE VERTEBRAL BODY DURING PEDIATRIC SPINE SURGERY WAS LINKED TO A RAPID AND SUDDEN ONSET OF ANAPHYLAXIS. THERE IS AN EMERGING BODY OF LITERATURE DEMONSTRATING THAT ADMINISTRATION OF THESE TOPICAL HEMOSTATIC AGENTS MAY INCREASE THE RISK OF MORBIDITY AND MORTALITY IN SPINE DEFORMITY SURGERY. THE SURGEON SHOULD WEIGH THE RISK AND BENEFITS OF USING THESE AGENTS WHILE REALIZING THAT IT IS DIFFICULT TO IDENTIFY AN AT-RISK GROUP. THOSE WITH CERTAIN FOOD SENSITIVITIES TO PORK OR BEEF; OR WHO HAD UNDERGONE PRIOR SURGERIES INVOLVING ZOOLOGIC MATERIALS MAY BENEFIT FROM SPECIFIC ALLERGY EVALUATION. IN OUR PRACTICE, WE HAVE STOPPED INJECTING HEMOSTATIC AGENTS INTO THE VERTEBRAL BODY THROUGH THE PEDICLE AND USE THEM JUDICIOUSLY IN SPINE DEFORMITY CASES, PREFERABLY ON BONE SURFACE OR IN SOFT TISSUE SPACES. THE AUTHORS RECOMMEND PRIMARY PREVENTION BY METICULOUS PATIENT HISTORY GATHERING ABOUT ALLERGY TO THESE PRODUCTS AND ADVISE CAUTION IF INJECTING THE MATERIAL INTO VASCULAR BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (23MAR2021): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4)), FOR ABSORBABLE GELATIN (GELFOAM). SEVERITY OF HARM WAS S4. SITE SAMPLE STATUS WAS NOT RECEIVED. PGS SAFETY SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. (PARENT) PRODUCT-DESCRIPTION: GELFOAM-JMI POWDER KIT 5000 IU. INVESTIGATION DECISION: FPRS EVALUATION COMMENT: PFIZER SAFETY SITE AGREES WITH THE INVESTIGATION DECISION, CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, AND JUSTIFICATION. SITE ASSIGNMENT TABLE WAS REVIEWED AND IS ACCURATE AND APPROPRIATE. AN INVESTIGATION WILL BE PERFORMED. NO REPEAT INVESTIGATION. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION WAS H03-04, FUNCTIONALITY - CRITICAL PERFORMANCE (INX100401277V1.0), AND THE WORST CASE SEVERITY WAS S4. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REQUIRING ESCALATION. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. MALFUNCTION IS NOT PRESENT IN THIS CASE (OFF-LABEL USE). NOTIFICATION WAS MADE TO THE DCHU OF PREVIOUS MDR FOR SIMILAR CASES. THIS IS A COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM JMI. THE INITIAL SCOPE ALL BATCHES PRODUCED WITHIN 24 MONTHS PRIOR TO RECEIPT OF THE REPORTED COMPLAINT AS THAT TIMEFRAME WILL CAPTURE ANY BATCHES WITHIN EXPIRY ON THE MARKET. THE COMPLAINT WILL INCLUDE REVIEW OF ANY PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS DETERMINED TO BE WITHIN SCOPE. THIS IS NOT PROCESS RELATED AND FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. ROOT CAUSE: PFIZER SAFETY SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SAFETY SITE PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SAFETY SITE. IMPACT ANALYSIS: QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO SAFETY SITE CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIONS, CORRECTIVE AND PREVENTATIVE ACTIONS: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS A REVIEW OF PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS FOR THE RELEVANT PRODUCT CLASS, SUB-CLASS RECEIVED WITHIN 36 MONTHS (THE LARGER EXPIRY INTERVAL OF THE PRODUCTS FOR GELFOAM) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. THE REQUIRED MINIMUM OF 5 DATA POINTS WAS CAPTURED; HOWEVER, OF ALL PREVIOUS INVESTIGATIONS, THERE WERE NONE WITH A KNOWN BATCH NUMBER FOR EITHER IMPLICATED PRODUCT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. INVESTIGATION: OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. THE SCOPE WAS NOT EXPANDED AS A RESULT OF INVESTIGATION. DOCUMENT REVIEW SUMMARY:DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. APRR REVIEW: COMPLETE - ACCEPTABLE. A REVIEW OF APRR FOR THE PRODUCTS AND TIMEFRAME IN SCOPE DID NOT FIND ANY ISSUE RELATED TO THE REPORTED COMPLAINT. QO BATCH HISTORY REPORT: A REVIEW OF RELEASE TESTING RESULTS COULD NOT BE PERFORMED AS THE REPORTED COMPLAINT BATCH IS UNKNOWN. RESERVE SAMPLE EVALUATION: VISUAL RESRV SAMPLE EVAL DESC.: BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION, ADDITIONALLY, THERE WERE NO COMPLAINTS WITH A KNOWN BATCH NUMBER DETERMINED TO BE WITHIN SCOPE FOR WHICH A PREVIOUS EXAMINATION OF RETAINED REFERENCE SAMPLES COULD BE REVIEWED. NO LOT-SPECIFIC TREND IDENTIFIED. LOT TREND ASSMT. & RATIONALE: COMPLETE-ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. LOT TREND ACTIONS TAKEN: NO BATCH TRENDS WERE IDENTIFIED; THEREFORE, NO BATCH TREND ACTIONS WERE REQUIRED. NO EXPEDITE TREND IDENTIFIED. NO OTHER TREND IDENTIFIED. OTHER TREND ASSMT. & RATIONALE: MEDICAL DEVICE REPORT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT HAD BEEN ISSUED; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO DCHU FOR EVALUATION OF REPORTABILITY. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR PRODUCTS WITH THE PRODUCT CATEGORY DEFINED AS 'ABSORBABLE MATERIAL', 'DELIVERY SYSTEM' AND 'TOPICAL' HAS BEEN REVIEWED. THE FOLLOWING PARAMETERS WERE USED: -PRODUCT CATEGORY: ABSORBABLE MATERIAL, DELIVERY SYSTEM, TOPICAL -TIME PERIOD: 23FEB2018 - 23FEB2021 -COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION -INVESTIGATING SITE: PFIZER KDP THE PRODUCT CATEGORY OF 'TOPICAL' WAS USED TO CAPTURE ANY OVERLAP IN COMPLAINTS INVOLVING THROMBIN NOT CAPTURED BY THE CATEGORIES 'ABSORBABLE MATERIAL' OR 'DELIVERY SYSTEM'. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (JANUARY 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. MEDICAL DEVICE COMPONENT TREND: A REVIEW OF TRENDS FOR MEDICAL DEVICE CONSTITUENTS FOR THE REPORTED PRODUCT COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. FOLLOW-UP (12APR2021): ADDITIONAL INFORMATION RECEIVED FROM PQCG INCLUDED INVESTIGATION RESULTS FOR THROMBIN. REASONABLY SUGGESTS DEVICE MALFUNCTION. FAILURE MODE: PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS/ ONSET OF ANAPHYLAXIS. THROMBI-GEL TOPICAL, THROMBI-GEL 10 THROMBIN/GELATIN FOAM HEMOSTAT, AND NOT A STERILE PRODUCT. INVESTIGATION DECISION, FPRS EVALUATION COMMENT: FOR THROMBI-GEL (AND RELATED THROMBI-PAD), CMO VASCULAR SOLUTION IS THE MARKET AUTHORIZATION HOLDER (MAH) AND DHF OWNER. THIS IS A 'PARTNER' / DISTRIBUTION ONLY RELATIONSHIP. PER THE QUALITY AGREEMENT, VASCULAR SOLUTION IS RESPONSIBLE FOR ALL ASPECTS OF COMPLAINT HANDLING, SAFETY, REPORTABILITY DECISIONS, MARKET ACTIONS, COMPLAINANT RESPONSE, AND RELATED ACTIVITIES. PFIZER/ESQ IS NOT INVOLVED IN COMPLAINTS FOR THROMBI-GEL. INFORMATION IN THIS COMPLAINT / LITERATURE REVIEW WILL BE 'PASSED THROUGH' TO VS. QA REVIEW & RATIONALE: DCHU REVIEWED THE CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, PRODUCT INFORMATION AND JUSTIFICATION. SITE ASSIGNMENT GRID WAS REVIEWED AND IS ACCURATE AND APPROPRIATE. AN INVESTIGATION WILL BE PERFORMED. A FULL INVESTIGATION WAS NOT PERFORMED THE DCHU AS PROVIDING THE BATCH RECORD INFORMATION IS THE MANUFACTURING SITE'S REQUIREMENT; THEREFORE, A SUMMARY INVESTIGATION WAS PERFORMED. THE FIELD FOR DEVICE MALFUNCTION IN CITI IS REQUIRED TO CONDITIONALLY POPULATE THE SEVERITY RANKING. THIS IS MEDICAL DEVICE RELATED. INVESTIGATION FINDINGS: SUMMARY OF INVESTIGATION: BASED ON THE COMPLAINT NARRATIVE: PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS INTO THE NON-EXPANDABLE CLOSED SPACE OF THE VERTEBRAL BODY DURING PEDIATRIC SPINE SURGERY WAS LINKED TO A RAPID AND SUDDEN ONSET OF ANAPHYLAXIS FOR THROMBI-GEL 10 THROMBIN/GELATIN FOAM HEMOSTAT. PROCESS RELATED WAS NOT APPLICABLE. FINAL CONFIRMATION STATUS: NOT CONFIRMED. SPECIAL OR COMMON CAUSE: COMMON CAUSE ROOT CAUSE IS ALWAYS PRESENT TO SOME DEGREE IN THE PROCESS. SPECIAL CAUSE ROOT CAUSE IS SOMETHING DIFFERENT HAPPENING AT A CERTAIN TIME OR PLACE IN THE PROCESS. RSRV. SAMPLE EVAL. RATIONALE WAS NOT PERFORMED BY DCHU. LOT-SPECIFIC TREND WAS NOT IDENTIFIED. AN EXPEDITE TREND WAS IDENTIFIED. SITE SAMPLE STATUS: NOT RECEIVED. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE: PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS INTO THE NON-EXPANDABLE CLOSED SPACE OF THE VERTEBRAL BODY DURING PEDIATRIC SPINE SURGERY WAS LINKED TO A RAPID AND SUDDEN ONSET OF ANAPHYLAXIS FOR THROMBI-GEL 10 THROMBIN/GELATIN FOAM HEMOSTAT. PER (B)(4) VASCULAR SOLUTIONS SITE INVESTIGATION PER THE (PARENT) FPRS EVALUATION COMMENT: FOR THROMBI-GEL (AND RELATED THROMBI-PAD), CMO VASCULAR SOLUTION IS THE MARKET AUTHORIZATION HOLDER (MAH) AND DHF OWNER. THIS IS A 'PARTNER' / DISTRIBUTION ONLY RELATIONSHIP. PER THE QUALITY AGREEMENT, VASCULAR SOLUTION IS RESPONSIBLE FOR ALL ASPECTS OF COMPLAINT HANDLING, SAFETY, REPORTABILITY DECISIONS, MARKET ACTIONS, COMPLAINANT RESPONSE, AND RELATED ACTIVITIES. PFIZER/ESQ IS NOT INVOLVED IN COMPLAINTS FOR THROMBI-GEL. INFORMATION IN THIS COMPLAINT / LITERATURE REVIEW WILL BE 'PASSED THROUGH' TO VS. THIS COMPLAINT FOR PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS INTO THE NON-EXPANDABLE CLOSED SPACE OF THE VERTEBRAL BODY DURING PEDIATRIC SPINE SURGERY WAS LINKED TO A RAPID AND SUDDEN ONSET OF ANAPHYLAXIS FOR THROMBIN IS REPORTABLE IN THE US AS A LIFE-THREATENING SERIOUS INJURY. THIS IS A 30-DAY US REPORTABLE. THIS IS ALSO A REPORTABLE MALFUNCTION. THIS PRODUCT IS USED FOR TREATMENT. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THIS PATIENT HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA WAS USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS WERE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. IT WAS NOTED THAT FOLLOWING PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERNS IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTIONS IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE. PFIZER IS A MARKETING AUTHORIZATION HOLDER OF THROMBIN IN THE COUNTRY OF INCIDENCE OR THE COUNTRY WHERE THE PRODUCT WAS PURCHASED (IF DIFFERENT). THIS MAY BE A DUPLICATE REPORT IF ANOTHER MARKETING AUTHORIZATION HOLDER OF THROMBIN HAS SUBMITTED THE SAME REPORT TO THE REGULATORY AUTHORITIES., COMMENT: BASED ON THE INFORMATION PROVIDED, THIS PATIENT HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA WAS USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS WERE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. IT WAS NOTED THAT FOLLOWING PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERNS IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTIONS IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM] ANAPHYLAXIS AFTER INJECTING A HEMOSTATIC AGENT CONTAINING GELATIN [ANAPHYLACTIC REACTION], , NARRATIVE: THIS IS A LITERATURE REPORT FROM SPINE DEFORMITY, 2021, (DOI: 10.1007/S43390-020-00273-4) ENTITLED, 'ANAPHYLAXIS AFTER INJECTING A HEMOSTATIC AGENT CONTAINING GELATIN INTO VERTEBRAL BONE UNDER PRESSURE-A WARNING.' CASE 1: A 7 1/2-YEAR-OLD BOY WITH CONGENITAL SCOLIOSIS AND SURGICALLY CORRECTED TETRALOGY OF FALLOT UNDERWENT HEMIVERTEBRA RESECTION AND POSTERIOR SPINAL INSTRUMENTATION WITH FUSION. DOCUMENTED ALLERGIES INCLUDED VERSED AND FENTANYL, WHICH CAUSED TACHYCARDIA AND CHEST PAIN. AT THE TIME OF SURGERY IN THE PRONE POSITION, T7-T10 WAS EXPOSED BILATERALLY. TOPICAL GELFOAM POWDER WITH THROMBIN WAS USED FOR HEMOSTASIS. AFTER THE LEFT T9 PEDICLE WAS ISOLATED, THE VERTEBRAL BODY WAS CANNULATED, AND SEVERAL MILLILITERS OF BOVINE-DERIVED HEMOSTATIC AGENT WERE INJECTED INTRAOSSEOUS UNDER MANUAL PRESSURE THROUGH A SYRINGE. APPROXIMATELY 10 MIN LATER, A TRANSIENT DECREASED BLOOD PRESSURE WAS NOTED AS WELL AS INCREASED END-TIDAL CO2 LEVELS. TWENTY MINUTES LATER, HEMODYNAMIC INSTABILITY WORSENED, THE HEART RATE WAS LOST AND THE VENTILATION BECAME MORE DIFFICULT. THE INCISION WAS RAPIDLY CLOSED, THE PATIENT THEN TRANSFERRED TO A BED IN THE SUPINE POSITION AND 20 MIN OF FULL CARDIAC RESUSCITATION AND CHEST COMPRESSIONS WAS PERFORMED BEFORE SPONTANEOUS CIRCULATION RETURNED. AN ECHOCARDIOGRAM OBTAINED AFTER THE RETURN OF SPONTANEOUS CIRCULATION SHOWED NORMAL CARDIAC FUNCTION AND NO EVIDENCE OF AIR EMBOLISM. ONE HOUR AFTER THE INTRAOSSEOUS GELATIN INJECTION, A GENERALIZED URTICARIAL RASH WAS NOTED, ACCOMPANIED BY AREAS OF SKIN HYPOPERFUSION. TRYPTASE LEVEL OBTAINED WITHIN 2 H OF THE EVENT WAS 22.7 NG/ ML (NL < 11.5). GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THERE WAS NO FURTHER HEMODYNAMIC INSTABILITY OR RECURRENCE OF SYMPTOMS IN THE INITIAL POSTOPERATIVE PHASE OF HIS CARE. HE WAS SUCCESSFULLY EXTUBATED ON A POSTOPERATIVE DAY ONE WITH A RESOLUTION OF HIS RASH AND IMPROVEMENT IN HIS CARDIOPULMONARY STATUS. AN ALLERGY AND IMMUNOLOGY CONSULTANT RECOMMENDED PRE-MEDICATING HIM WITH PREDNISONE 24 MG TWICE DAILY, CETIRIZINE 5 MG TWICE DAILY AND RANITIDINE 75 MG TWICE DAILY FOR 48 H BEFORE RETURNING TO THE OPERATING ROOM. THE CONSULTANT ALSO RECOMMENDED THAT THE BEST WAY TO ASSESS ALLERGENS TO THESE MEDICATIONS WAS AFTER HE HAD BEEN OFF OF ANTIHISTAMINES FOR 7 DAYS. THE SURGERY WAS COMPLETED THE FOLLOWING WEEK, WITHOUT THE USE OF LIQUID GELATIN PRODUCTS AND HIS POSTOPERATIVE COURSE WAS OTHERWISE UNEVENTFUL. RADIO-ALLERGOSORBENT TESTING (RAST) SHOWED ELEVATED IGE LEVELS TO BOVINE GELATIN (7.1; NL < 3.5). DISCUSSION: THE AUTHORS PRESENT A CASE IN WHICH PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. ANAPHYLAXIS OCCURRED SHORTLY AFTER THE INJECTION OF HEMOSTATIC AGENTS INTO THE ENCLOSED SPACE OF THE VERTEBRAL BODY. THE CASES HAD CARDIOVASCULAR COLLAPSE, SKIN CHANGES, AND ELEVATED TRYPTASE LEVELS. CASE 1 HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA CAN BE USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS ARE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. THE RATE AT WHICH THESE MATERIALS DISSEMINATE FROM BONE IS RAPID, AS SHOWN BY THE PATIENT DESCRIBED IN THIS SERIES, WHO DEVELOPED ANAPHYLAXIS WITHIN MINUTES OF INJECTION INTO THE VERTEBRAL BODY. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS (REFERENCE).BOVINE THROMBIN MAY CAUSE HYPOTENSION AND EVEN DIC AT DOSES OF 60 U/KG (REFERENCE). THE PATIENT DEVELOPED HYPOTENSION, BRONCHOSPASM AND RASH, WITH A RAPID TEMPORAL RELATIONSHIP BETWEEN ADMINISTRATION OF THE MATERIAL AND THE ONSET OF SYMPTOMS.IN SUMMARY, THE AUTHORS DESCRIBE A CASE IN WHICH PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS INTO THE NON-EXPANDABLE CLOSED SPACE OF THE VERTEBRAL BODY DURING PEDIATRIC SPINE SURGERY WAS LINKED TO A RAPID AND SUDDEN ONSET OF ANAPHYLAXIS. THERE IS AN EMERGING BODY OF LITERATURE DEMONSTRATING THAT ADMINISTRATION OF THESE TOPICAL HEMOSTATIC AGENTS MAY INCREASE THE RISK OF MORBIDITY AND MORTALITY IN SPINE DEFORMITY SURGERY. THE SURGEON SHOULD WEIGH THE RISK AND BENEFITS OF USING THESE AGENTS WHILE REALIZING THAT IT IS DIFFICULT TO IDENTIFY AN AT-RISK GROUP. THOSE WITH CERTAIN FOOD SENSITIVITIES TO PORK OR BEEF; OR WHO HAD UNDERGONE PRIOR SURGERIES INVOLVING ZOOLOGIC MATERIALS MAY BENEFIT FROM SPECIFIC ALLERGY EVALUATION. IN OUR PRACTICE, WE HAVE STOPPED INJECTING HEMOSTATIC AGENTS INTO THE VERTEBRAL BODY THROUGH THE PEDICLE AND USE THEM JUDICIOUSLY IN SPINE DEFORMITY CASES, PREFERABLY ON BONE SURFACE OR IN SOFT TISSUE SPACES. THE AUTHORS RECOMMEND PRIMARY PREVENTION BY METICULOUS PATIENT HISTORY GATHERING ABOUT ALLERGY TO THESE PRODUCTS AND ADVISE CAUTION IF INJECTING THE MATERIAL INTO VASCULAR BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (23MAR2021): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4)), FOR ABSORBABLE GELATIN (GELFOAM). SEVERITY OF HARM WAS S4. SITE SAMPLE STATUS WAS NOT RECEIVED. PGS SAFETY SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. (PARENT) PRODUCT-DESCRIPTION: GELFOAM-JMI POWDER KIT 5000 IU. INVESTIGATION DECISION: FPRS EVALUATION COMMENT: PFIZER SAFETY SITE AGREES WITH THE INVESTIGATION DECISION, CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, AND JUSTIFICATION. SITE ASSIGNMENT TABLE WAS REVIEWED AND IS ACCURATE AND APPROPRIATE. AN INVESTIGATION WILL BE PERFORMED. NO REPEAT INVESTIGATION. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION WAS H03-04, FUNCTIONALITY - CRITICAL PERFORMANCE (INX100401277V1.0), AND THE WORST CASE SEVERITY WAS S4. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REQUIRING ESCALATION. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. MALFUNCTION IS NOT PRESENT IN THIS CASE (OFF-LABEL USE). NOTIFICATION WAS MADE TO THE DCHU OF PREVIOUS MDR FOR SIMILAR CASES. THIS IS A COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM JMI. THE INITIAL SCOPE ALL BATCHES PRODUCED WITHIN 24 MONTHS PRIOR TO RECEIPT OF THE REPORTED COMPLAINT AS THAT TIMEFRAME WILL CAPTURE ANY BATCHES WITHIN EXPIRY ON THE MARKET. THE COMPLAINT WILL INCLUDE REVIEW OF ANY PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS DETERMINED TO BE WITHIN SCOPE. THIS IS NOT PROCESS RELATED AND FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. ROOT CAUSE: PFIZER SAFETY SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SAFETY SITE PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SAFETY SITE. IMPACT ANALYSIS: QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO SAFETY SITE CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIONS, CORRECTIVE AND PREVENTATIVE ACTIONS: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS A REVIEW OF PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS FOR THE RELEVANT PRODUCT CLASS, SUB-CLASS RECEIVED WITHIN 36 MONTHS (THE LARGER EXPIRY INTERVAL OF THE PRODUCTS FOR GELFOAM) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. THE REQUIRED MINIMUM OF 5 DATA POINTS WAS CAPTURED; HOWEVER, OF ALL PREVIOUS INVESTIGATIONS, THERE WERE NONE WITH A KNOWN BATCH NUMBER FOR EITHER IMPLICATED PRODUCT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. INVESTIGATION: OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. THE SCOPE WAS NOT EXPANDED AS A RESULT OF INVESTIGATION. DOCUMENT REVIEW SUMMARY:DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. APRR REVIEW: COMPLETE - ACCEPTABLE. A REVIEW OF APRR FOR THE PRODUCTS AND TIMEFRAME IN SCOPE DID NOT FIND ANY ISSUE RELATED TO THE REPORTED COMPLAINT. QO BATCH HISTORY REPORT: A REVIEW OF RELEASE TESTING RESULTS COULD NOT BE PERFORMED AS THE REPORTED COMPLAINT BATCH IS UNKNOWN. RESERVE SAMPLE EVALUATION: VISUAL RESRV SAMPLE EVAL DESC.: BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION, ADDITIONALLY, THERE WERE NO COMPLAINTS WITH A KNOWN BATCH NUMBER DETERMINED TO BE WITHIN SCOPE FOR WHICH A PREVIOUS EXAMINATION OF RETAINED REFERENCE SAMPLES COULD BE REVIEWED. NO LOT-SPECIFIC TREND IDENTIFIED. LOT TREND ASSMT. & RATIONALE: COMPLETE-ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. LOT TREND ACTIONS TAKEN: NO BATCH TRENDS WERE IDENTIFIED; THEREFORE, NO BATCH TREND ACTIONS WERE REQUIRED. NO EXPEDITE TREND IDENTIFIED. NO OTHER TREND IDENTIFIED. OTHER TREND ASSMT. & RATIONALE: MEDICAL DEVICE REPORT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT HAD BEEN ISSUED; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO DCHU FOR EVALUATION OF REPORTABILITY. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR PRODUCTS WITH THE PRODUCT CATEGORY DEFINED AS 'ABSORBABLE MATERIAL', 'DELIVERY SYSTEM' AND 'TOPICAL' HAS BEEN REVIEWED. THE FOLLOWING PARAMETERS WERE USED: -PRODUCT CATEGORY: ABSORBABLE MATERIAL, DELIVERY SYSTEM, TOPICAL -TIME PERIOD: 23FEB2018 - 23FEB2021 -COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION -INVESTIGATING SITE: PFIZER KDP THE PRODUCT CATEGORY OF 'TOPICAL' WAS USED TO CAPTURE ANY OVERLAP IN COMPLAINTS INVOLVING THROMBIN NOT CAPTURED BY THE CATEGORIES 'ABSORBABLE MATERIAL' OR 'DELIVERY SYSTEM'. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH ((B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS ((B)(4)); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS ((B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS ((B)(4), RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. MEDICAL DEVICE COMPONENT TREND: A REVIEW OF TRENDS FOR MEDICAL DEVICE CONSTITUENTS FOR THE REPORTED PRODUCT COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. FOLLOW-UP (12APR2021): ADDITIONAL INFORMATION RECEIVED FROM PQCG INCLUDED INVESTIGATION RESULTS FOR THROMBIN. REASONABLY SUGGESTS DEVICE MALFUNCTION. FAILURE MODE: PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS/ ONSET OF ANAPHYLAXIS. THROMBI-GEL TOPICAL, THROMBI-GEL 10 THROMBIN/GELATIN FOAM HEMOSTAT, AND NOT A STERILE PRODUCT. INVESTIGATION DECISION, FPRS EVALUATION COMMENT: FOR THROMBI-GEL (AND RELATED THROMBI-PAD), CMO VASCULAR SOLUTION IS THE MARKET AUTHORIZATION HOLDER (MAH) AND DHF OWNER. THIS IS A 'PARTNER' / DISTRIBUTION ONLY RELATIONSHIP. PER THE QUALITY AGREEMENT, VASCULAR SOLUTION IS RESPONSIBLE FOR ALL ASPECTS OF COMPLAINT HANDLING, SAFETY, REPORTABILITY DECISIONS, MARKET ACTIONS, COMPLAINANT RESPONSE, AND RELATED ACTIVITIES. PFIZER/ESQ IS NOT INVOLVED IN COMPLAINTS FOR THROMBI-GEL. INFORMATION IN THIS COMPLAINT / LITERATURE REVIEW WILL BE 'PASSED THROUGH' TO VS. QA REVIEW & RATIONALE: DCHU REVIEWED THE CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, PRODUCT INFORMATION AND JUSTIFICATION. SITE ASSIGNMENT GRID WAS REVIEWED AND IS ACCURATE AND APPROPRIATE. AN INVESTIGATION WILL BE PERFORMED. A FULL INVESTIGATION WAS NOT PERFORMED THE DCHU AS PROVIDING THE BATCH RECORD INFORMATION IS THE MANUFACTURING SITE'S REQUIREMENT; THEREFORE, A SUMMARY INVESTIGATION WAS PERFORMED. THE FIELD FOR DEVICE MALFUNCTION IN CITI IS REQUIRED TO CONDITIONALLY POPULATE THE SEVERITY RANKING. THIS IS MEDICAL DEVICE RELATED. INVESTIGATION FINDINGS: SUMMARY OF INVESTIGATION: BASED ON THE COMPLAINT NARRATIVE: PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS INTO THE NON-EXPANDABLE CLOSED SPACE OF THE VERTEBRAL BODY DURING PEDIATRIC SPINE SURGERY WAS LINKED TO A RAPID AND SUDDEN ONSET OF ANAPHYLAXIS FOR THROMBI-GEL 10 THROMBIN/GELATIN FOAM HEMOSTAT. PROCESS RELATED WAS NOT APPLICABLE. FINAL CONFIRMATION STATUS: NOT CONFIRMED. SPECIAL OR COMMON CAUSE: COMMON CAUSE ROOT CAUSE IS ALWAYS PRESENT TO SOME DEGREE IN THE PROCESS. SPECIAL CAUSE ROOT CAUSE IS SOMETHING DIFFERENT HAPPENING AT A CERTAIN TIME OR PLACE IN THE PROCESS. RSRV. SAMPLE EVAL. RATIONALE WAS NOT PERFORMED BY DCHU. LOT-SPECIFIC TREND WAS NOT IDENTIFIED. AN EXPEDITE TREND WAS IDENTIFIED. SITE SAMPLE STATUS: NOT RECEIVED. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE: PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS INTO THE NON-EXPANDABLE CLOSED SPACE OF THE VERTEBRAL BODY DURING PEDIATRIC SPINE SURGERY WAS LINKED TO A RAPID AND SUDDEN ONSET OF ANAPHYLAXIS FOR THROMBI-GEL 10 THROMBIN/GELATIN FOAM HEMOSTAT. PER PR 5691521 VASCULAR SOLUTIONS SITE INVESTIGATION PER THE (PARENT) FPRS EVALUATION COMMENT: FOR THROMBI-GEL (AND RELATED THROMBI-PAD), CMO VASCULAR SOLUTION IS THE MARKET AUTHORIZATION HOLDER (MAH) AND DHF OWNER. THIS IS A 'PARTNER' / DISTRIBUTION ONLY RELATIONSHIP. PER THE QUALITY AGREEMENT, VASCULAR SOLUTION IS RESPONSIBLE FOR ALL ASPECTS OF COMPLAINT HANDLING, SAFETY, REPORTABILITY DECISIONS, MARKET ACTIONS, COMPLAINANT RESPONSE, AND RELATED ACTIVITIES. PFIZER/ESQ IS NOT INVOLVED IN COMPLAINTS FOR THROMBI-GEL. INFORMATION IN THIS COMPLAINT / LITERATURE REVIEW WILL BE 'PASSED THROUGH' TO VS. THIS COMPLAINT FOR PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS INTO THE NON-EXPANDABLE CLOSED SPACE OF THE VERTEBRAL BODY DURING PEDIATRIC SPINE SURGERY WAS LINKED TO A RAPID AND SUDDEN ONSET OF ANAPHYLAXIS FOR THROMBIN IS REPORTABLE IN THE US AS A LIFE-THREATING SERIOUS INJURY. THIS IS A 30-DAY US REPORTABLE. THIS IS ALSO A REPORTABLE MALFUNCTION. THIS PRODUCT IS USED FOR TREATMENT. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THIS PATIENT HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA WAS USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS WERE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. IT WAS NOTED THAT FOLLOWING PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERNS IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTIONS IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE. PFIZER IS A MARKETING AUTHORIZATION HOLDER OF THROMBIN IN THE COUNTRY OF INCIDENCE OR THE COUNTRY WHERE THE PRODUCT WAS PURCHASED (IF DIFFERENT). THIS MAY BE A DUPLICATE REPORT IF ANOTHER MARKETING AUTHORIZATION HOLDER OF THROMBIN HAS SUBMITTED THE SAME REPORT TO THE REGULATORY AUTHORITIES. FOLLOW-UP (06JUN2022): THIS IS A LITERATURE REPORT FROM THE LITERATURE SOURCE ENTITLED ANAPHYLAXIS AFTER INJECTING A HEMOSTATIC AGENT CONTAINING GELATIN INTO VERTEBRAL BONE UNDER PRESSURE-A WARNING,SPINE DEFORMITY, 2021,VOL: 9(4), PP:1191-1196, DOI: 10.1007/S43390-020-00273-4. THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION. UPDATED INFORMATION INCLUDED: LITERATURE INFORMATION(VOLUME AND PAGE NUMBER GOT UPDATED) AS PER CURRENT FOLLOWUP ABSTRACT., COMMENT: BASED ON THE INFORMATION PROVIDED, THIS PATIENT HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA WAS USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS WERE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. IT WAS NOTED THAT FOLLOWING PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERNS IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTIONS IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM] ANAPHYLAXIS AFTER INJECTING A HEMOSTATIC AGENT CONTAINING GELATIN [ANAPHYLACTIC REACTION], , NARRATIVE: THIS IS A LITERATURE REPORT FROM SPINE DEFORMITY, 2021, (DOI: 10.1007/S43390-020-00273-4) ENTITLED, 'ANAPHYLAXIS AFTER INJECTING A HEMOSTATIC AGENT CONTAINING GELATIN INTO VERTEBRAL BONE UNDER PRESSURE-A WARNING.' CASE 1: A 7 1/2-YEAR-OLD BOY WITH CONGENITAL SCOLIOSIS AND SURGICALLY CORRECTED TETRALOGY OF FALLOT UNDERWENT HEMIVERTEBRA RESECTION AND POSTERIOR SPINAL INSTRUMENTATION WITH FUSION. DOCUMENTED ALLERGIES INCLUDED VERSED AND FENTANYL, WHICH CAUSED TACHYCARDIA AND CHEST PAIN. AT THE TIME OF SURGERY IN THE PRONE POSITION, T7-T10 WAS EXPOSED BILATERALLY. TOPICAL GELFOAM POWDER WITH THROMBIN WAS USED FOR HEMOSTASIS. AFTER THE LEFT T9 PEDICLE WAS ISOLATED, THE VERTEBRAL BODY WAS CANNULATED, AND SEVERAL MILLILITERS OF BOVINE-DERIVED HEMOSTATIC AGENT WERE INJECTED INTRAOSSEOUS UNDER MANUAL PRESSURE THROUGH A SYRINGE. APPROXIMATELY 10 MIN LATER, A TRANSIENT DECREASED BLOOD PRESSURE WAS NOTED AS WELL AS INCREASED END-TIDAL CO2 LEVELS. TWENTY MINUTES LATER, HEMODYNAMIC INSTABILITY WORSENED, THE HEART RATE WAS LOST AND THE VENTILATION BECAME MORE DIFFICULT. THE INCISION WAS RAPIDLY CLOSED, THE PATIENT THEN TRANSFERRED TO A BED IN THE SUPINE POSITION AND 20 MIN OF FULL CARDIAC RESUSCITATION AND CHEST COMPRESSIONS WAS PERFORMED BEFORE SPONTANEOUS CIRCULATION RETURNED. AN ECHOCARDIOGRAM OBTAINED AFTER THE RETURN OF SPONTANEOUS CIRCULATION SHOWED NORMAL CARDIAC FUNCTION AND NO EVIDENCE OF AIR EMBOLISM. ONE HOUR AFTER THE INTRAOSSEOUS GELATIN INJECTION, A GENERALIZED URTICARIAL RASH WAS NOTED, ACCOMPANIED BY AREAS OF SKIN HYPOPERFUSION. TRYPTASE LEVEL OBTAINED WITHIN 2 H OF THE EVENT WAS 22.7 NG/ ML (NL < 11.5). GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THERE WAS NO FURTHER HEMODYNAMIC INSTABILITY OR RECURRENCE OF SYMPTOMS IN THE INITIAL POSTOPERATIVE PHASE OF HIS CARE. HE WAS SUCCESSFULLY EXTUBATED ON A POSTOPERATIVE DAY ONE WITH A RESOLUTION OF HIS RASH AND IMPROVEMENT IN HIS CARDIOPULMONARY STATUS. AN ALLERGY AND IMMUNOLOGY CONSULTANT RECOMMENDED PRE-MEDICATING HIM WITH PREDNISONE 24 MG TWICE DAILY, CETIRIZINE 5 MG TWICE DAILY AND RANITIDINE 75 MG TWICE DAILY FOR 48 H BEFORE RETURNING TO THE OPERATING ROOM. THE CONSULTANT ALSO RECOMMENDED THAT THE BEST WAY TO ASSESS ALLERGENS TO THESE MEDICATIONS WAS AFTER HE HAD BEEN OFF OF ANTIHISTAMINES FOR 7 DAYS. THE SURGERY WAS COMPLETED THE FOLLOWING WEEK, WITHOUT THE USE OF LIQUID GELATIN PRODUCTS AND HIS POSTOPERATIVE COURSE WAS OTHERWISE UNEVENTFUL. RADIO-ALLERGOSORBENT TESTING (RAST) SHOWED ELEVATED IGE LEVELS TO BOVINE GELATIN (7.1; NL < 3.5). DISCUSSION: THE AUTHORS PRESENT A CASE IN WHICH PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. ANAPHYLAXIS OCCURRED SHORTLY AFTER THE INJECTION OF HEMOSTATIC AGENTS INTO THE ENCLOSED SPACE OF THE VERTEBRAL BODY. THE CASES HAD CARDIOVASCULAR COLLAPSE, SKIN CHANGES, AND ELEVATED TRYPTASE LEVELS. CASE 1 HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA CAN BE USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS ARE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. THE RATE AT WHICH THESE MATERIALS DISSEMINATE FROM BONE IS RAPID, AS SHOWN BY THE PATIENT DESCRIBED IN THIS SERIES, WHO DEVELOPED ANAPHYLAXIS WITHIN MINUTES OF INJECTION INTO THE VERTEBRAL BODY. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS (REFERENCE). BOVINE THROMBIN MAY CAUSE HYPOTENSION AND EVEN DIC AT DOSES OF 60 U/KG (REFERENCE). THE PATIENT DEVELOPED HYPOTENSION, BRONCHOSPASM AND RASH, WITH A RAPID TEMPORAL RELATIONSHIP BETWEEN ADMINISTRATION OF THE MATERIAL AND THE ONSET OF SYMPTOMS. IN SUMMARY, THE AUTHORS DESCRIBE A CASE IN WHICH PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS INTO THE NON-EXPANDABLE CLOSED SPACE OF THE VERTEBRAL BODY DURING PEDIATRIC SPINE SURGERY WAS LINKED TO A RAPID AND SUDDEN ONSET OF ANAPHYLAXIS. THERE IS AN EMERGING BODY OF LITERATURE DEMONSTRATING THAT ADMINISTRATION OF THESE TOPICAL HEMOSTATIC AGENTS MAY INCREASE THE RISK OF MORBIDITY AND MORTALITY IN SPINE DEFORMITY SURGERY. THE SURGEON SHOULD WEIGH THE RISK AND BENEFITS OF USING THESE AGENTS WHILE REALIZING THAT IT IS DIFFICULT TO IDENTIFY AN AT-RISK GROUP. THOSE WITH CERTAIN FOOD SENSITIVITIES TO PORK OR BEEF; OR WHO HAD UNDERGONE PRIOR SURGERIES INVOLVING ZOOLOGIC MATERIALS MAY BENEFIT FROM SPECIFIC ALLERGY EVALUATION. IN OUR PRACTICE, WE HAVE STOPPED INJECTING HEMOSTATIC AGENTS INTO THE VERTEBRAL BODY THROUGH THE PEDICLE AND USE THEM JUDICIOUSLY IN SPINE DEFORMITY CASES, PREFERABLY ON BONE SURFACE OR IN SOFT TISSUE SPACES. THE AUTHORS RECOMMEND PRIMARY PREVENTION BY METICULOUS PATIENT HISTORY GATHERING ABOUT ALLERGY TO THESE PRODUCTS AND ADVISE CAUTION IF INJECTING THE MATERIAL INTO VASCULAR BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (23MAR2021): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4)), FOR ABSORBABLE GELATIN (GELFOAM). SEVERITY OF HARM WAS S4. SITE SAMPLE STATUS WAS NOT RECEIVED. PGS SAFETY SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. (PARENT) PRODUCT-DESCRIPTION: GELFOAM-JMI POWDER KIT 5000 IU. INVESTIGATION DECISION: FPRS EVALUATION COMMENT: PFIZER SAFETY SITE AGREES WITH THE INVESTIGATION DECISION, CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, AND JUSTIFICATION. SITE ASSIGNMENT TABLE WAS REVIEWED AND IS ACCURATE AND APPROPRIATE. AN INVESTIGATION WILL BE PERFORMED. NO REPEAT INVESTIGATION. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION WAS H03-04, FUNCTIONALITY - CRITICAL PERFORMANCE (INX100401277V1.0), AND THE WORST CASE SEVERITY WAS S4. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REQUIRING ESCALATION. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. MALFUNCTION IS NOT PRESENT IN THIS CASE (OFF-LABEL USE). NOTIFICATION WAS MADE TO THE DCHU OF PREVIOUS MDR FOR SIMILAR CASES. THIS IS A COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM JMI. THE INITIAL SCOPE ALL BATCHES PRODUCED WITHIN 24 MONTHS PRIOR TO RECEIPT OF THE REPORTED COMPLAINT AS THAT TIMEFRAME WILL CAPTURE ANY BATCHES WITHIN EXPIRY ON THE MARKET. THE COMPLAINT WILL INCLUDE REVIEW OF ANY PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS DETERMINED TO BE WITHIN SCOPE. THIS IS NOT PROCESS RELATED AND FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. ROOT CAUSE: PFIZER SAFETY SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SAFETY SITE PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SAFETY SITE. IMPACT ANALYSIS: QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO SAFETY SITE CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIONS, CORRECTIVE AND PREVENTATIVE ACTIONS: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE COMPLAINT FOR ADVERSE EVENT/SERIOUS/UNKNOWN FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS A REVIEW OF PREVIOUSLY COMPLETED COMPLAINT INVESTIGATIONS FOR THE RELEVANT PRODUCT CLASS, SUB-CLASS RECEIVED WITHIN 36 MONTHS (THE LARGER EXPIRY INTERVAL OF THE PRODUCTS FOR GELFOAM) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. THE REQUIRED MINIMUM OF 5 DATA POINTS WAS CAPTURED; HOWEVER, OF ALL PREVIOUS INVESTIGATIONS, THERE WERE NONE WITH A KNOWN BATCH NUMBER FOR EITHER IMPLICATED PRODUCT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. INVESTIGATION: OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. THE SCOPE WAS NOT EXPANDED AS A RESULT OF INVESTIGATION. DOCUMENT REVIEW SUMMARY: DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE. A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. APRR REVIEW: COMPLETE - ACCEPTABLE. A REVIEW OF APRR FOR THE PRODUCTS AND TIMEFRAME IN SCOPE DID NOT FIND ANY ISSUE RELATED TO THE REPORTED COMPLAINT. QO BATCH HISTORY REPORT: A REVIEW OF RELEASE TESTING RESULTS COULD NOT BE PERFORMED AS THE REPORTED COMPLAINT BATCH IS UNKNOWN. RESERVE SAMPLE EVALUATION: VISUAL RESRV SAMPLE EVAL DESC.: BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION, ADDITIONALLY, THERE WERE NO COMPLAINTS WITH A KNOWN BATCH NUMBER DETERMINED TO BE WITHIN SCOPE FOR WHICH A PREVIOUS EXAMINATION OF RETAINED REFERENCE SAMPLES COULD BE REVIEWED. NO LOT-SPECIFIC TREND IDENTIFIED. LOT TREND ASSMT. & RATIONALE: COMPLETE-ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. LOT TREND ACTIONS TAKEN: NO BATCH TRENDS WERE IDENTIFIED; THEREFORE, NO BATCH TREND ACTIONS WERE REQUIRED. NO EXPEDITE TREND IDENTIFIED. NO OTHER TREND IDENTIFIED. OTHER TREND ASSMT. & RATIONALE: MEDICAL DEVICE REPORT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT HAD BEEN ISSUED; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO DCHU FOR EVALUATION OF REPORTABILITY. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR PRODUCTS WITH THE PRODUCT CATEGORY DEFINED AS 'ABSORBABLE MATERIAL', 'DELIVERY SYSTEM' AND 'TOPICAL' HAS BEEN REVIEWED. THE FOLLOWING PARAMETERS WERE USED: -PRODUCT CATEGORY: ABSORBABLE MATERIAL, DELIVERY SYSTEM, TOPICAL -TIME PERIOD: 23FEB2018 - 23FEB2021 -COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION -INVESTIGATING SITE: PFIZER KDP THE PRODUCT CATEGORY OF 'TOPICAL' WAS USED TO CAPTURE ANY OVERLAP IN COMPLAINTS INVOLVING THROMBIN NOT CAPTURED BY THE CATEGORIES 'ABSORBABLE MATERIAL' OR 'DELIVERY SYSTEM'. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (JANUARY 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. MEDICAL DEVICE COMPONENT TREND: A REVIEW OF TRENDS FOR MEDICAL DEVICE CONSTITUENTS FOR THE REPORTED PRODUCT COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THIS PATIENT HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA WAS USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS WERE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. IT WAS NOTED THAT FOLLOWING PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERNS IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTIONS IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE. PFIZER IS A MARKETING AUTHORIZATION HOLDER OF THROMBIN IN THE COUNTRY OF INCIDENCE OR THE COUNTRY WHERE THE PRODUCT WAS PURCHASED (IF DIFFERENT). THIS MAY BE A DUPLICATE REPORT IF ANOTHER MARKETING AUTHORIZATION HOLDER OF THROMBIN HAS SUBMITTED THE SAME REPORT TO THE REGULATORY AUTHORITIES., COMMENT: BASED ON THE INFORMATION PROVIDED, THIS PATIENT HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA WAS USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS WERE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. IT WAS NOTED THAT FOLLOWING PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERNS IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTIONS IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM]. ANAPHYLAXIS AFTER INJECTING A HEMOSTATIC AGENT CONTAINING GELATIN [ANAPHYLACTIC REACTION]. NARRATIVE: THIS IS A LITERATURE REPORT FROM SPINE DEFORMITY, 2021, (DOI: 10.1007/S43390-020-00273-4) ENTITLED, 'ANAPHYLAXIS AFTER INJECTING A HEMOSTATIC AGENT CONTAINING GELATIN INTO VERTEBRAL BONE UNDER PRESSURE-A WARNING.' CASE 1: A (B)(6) YEAR-OLD BOY WITH CONGENITAL SCOLIOSIS AND SURGICALLY CORRECTED TETRALOGY OF FALLOT UNDERWENT HEMIVERTEBRA RESECTION AND POSTERIOR SPINAL INSTRUMENTATION WITH FUSION. DOCUMENTED ALLERGIES INCLUDED VERSED AND FENTANYL, WHICH CAUSED TACHYCARDIA AND CHEST PAIN. AT THE TIME OF SURGERY IN THE PRONE POSITION, T7-T10 WAS EXPOSED BILATERALLY. TOPICAL GELFOAM POWDER WITH THROMBIN WAS USED FOR HEMOSTASIS. AFTER THE LEFT T9 PEDICLE WAS ISOLATED, THE VERTEBRAL BODY WAS CANNULATED, AND SEVERAL MILLILITERS OF BOVINE-DERIVED HEMOSTATIC AGENT WERE INJECTED INTRAOSSEOUS UNDER MANUAL PRESSURE THROUGH A SYRINGE. APPROXIMATELY 10 MIN LATER, A TRANSIENT DECREASED BLOOD PRESSURE WAS NOTED AS WELL AS INCREASED END-TIDAL CO2 LEVELS. TWENTY MINUTES LATER, HEMODYNAMIC INSTABILITY WORSENED, THE HEART RATE WAS LOST AND THE VENTILATION BECAME MORE DIFFICULT. THE INCISION WAS RAPIDLY CLOSED, THE PATIENT THEN TRANSFERRED TO A BED IN THE SUPINE POSITION AND 20 MIN OF FULL CARDIAC RESUSCITATION AND CHEST COMPRESSIONS WAS PERFORMED BEFORE SPONTANEOUS CIRCULATION RETURNED. AN ECHOCARDIOGRAM OBTAINED AFTER THE RETURN OF SPONTANEOUS CIRCULATION SHOWED NORMAL CARDIAC FUNCTION AND NO EVIDENCE OF AIR EMBOLISM. ONE HOUR AFTER THE INTRAOSSEOUS GELATIN INJECTION, A GENERALIZED URTICARIAL RASH WAS NOTED, ACCOMPANIED BY AREAS OF SKIN HYPOPERFUSION. TRYPTASE LEVEL OBTAINED WITHIN 2 H OF THE EVENT WAS 22.7 NG/ ML (NL < 11.5). GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THERE WAS NO FURTHER HEMODYNAMIC INSTABILITY OR RECURRENCE OF SYMPTOMS IN THE INITIAL POSTOPERATIVE PHASE OF HIS CARE. HE WAS SUCCESSFULLY EXTUBATED ON A POSTOPERATIVE DAY ONE WITH A RESOLUTION OF HIS RASH AND IMPROVEMENT IN HIS CARDIOPULMONARY STATUS. AN ALLERGY AND IMMUNOLOGY CONSULTANT RECOMMENDED PRE-MEDICATING HIM WITH PREDNISONE 24 MG TWICE DAILY, CETIRIZINE 5 MG TWICE DAILY AND RANITIDINE 75 MG TWICE DAILY FOR 48 H BEFORE RETURNING TO THE OPERATING ROOM. THE CONSULTANT ALSO RECOMMENDED THAT THE BEST WAY TO ASSESS ALLERGENS TO THESE MEDICATIONS WAS AFTER HE HAD BEEN OFF OF ANTIHISTAMINES FOR 7 DAYS. THE SURGERY WAS COMPLETED THE FOLLOWING WEEK, WITHOUT THE USE OF LIQUID GELATIN PRODUCTS AND HIS POSTOPERATIVE COURSE WAS OTHERWISE UNEVENTFUL. RADIO-ALLERGOSORBENT TESTING (RAST) SHOWED ELEVATED IGE LEVELS TO BOVINE GELATIN (7.1; NL < 3.5). DISCUSSION: THE AUTHORS PRESENT A CASE IN WHICH PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. ANAPHYLAXIS OCCURRED SHORTLY AFTER THE INJECTION OF HEMOSTATIC AGENTS INTO THE ENCLOSED SPACE OF THE VERTEBRAL BODY. THE CASES HAD CARDIOVASCULAR COLLAPSE, SKIN CHANGES, AND ELEVATED TRYPTASE LEVELS. CASE 1 HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA CAN BE USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS ARE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. THE RATE AT WHICH THESE MATERIALS DISSEMINATE FROM BONE IS RAPID, AS SHOWN BY THE PATIENT DESCRIBED IN THIS SERIES, WHO DEVELOPED ANAPHYLAXIS WITHIN MINUTES OF INJECTION INTO THE VERTEBRAL BODY. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS (REFERENCE). BOVINE THROMBIN MAY CAUSE HYPOTENSION AND EVEN DIC AT DOSES OF 60 U/KG (REFERENCE). THE PATIENT DEVELOPED HYPOTENSION, BRONCHOSPASM AND RASH, WITH A RAPID TEMPORAL RELATIONSHIP BETWEEN ADMINISTRATION OF THE MATERIAL AND THE ONSET OF SYMPTOMS. IN SUMMARY, THE AUTHORS DESCRIBE A CASE IN WHICH PRESSURIZED ADMINISTRATION OF TOPICAL HEMOSTATIC AGENTS INTO THE NON-EXPANDABLE CLOSED SPACE OF THE VERTEBRAL BODY DURING PEDIATRIC SPINE SURGERY WAS LINKED TO A RAPID AND SUDDEN ONSET OF ANAPHYLAXIS. THERE IS AN EMERGING BODY OF LITERATURE DEMONSTRATING THAT ADMINISTRATION OF THESE TOPICAL HEMOSTATIC AGENTS MAY INCREASE THE RISK OF MORBIDITY AND MORTALITY IN SPINE DEFORMITY SURGERY. THE SURGEON SHOULD WEIGH THE RISK AND BENEFITS OF USING THESE AGENTS WHILE REALIZING THAT IT IS DIFFICULT TO IDENTIFY AN AT-RISK GROUP. THOSE WITH CERTAIN FOOD SENSITIVITIES TO PORK OR BEEF; OR WHO HAD UNDERGONE PRIOR SURGERIES INVOLVING ZOOLOGIC MATERIALS MAY BENEFIT FROM SPECIFIC ALLERGY EVALUATION. IN OUR PRACTICE, WE HAVE STOPPED INJECTING HEMOSTATIC AGENTS INTO THE VERTEBRAL BODY THROUGH THE PEDICLE AND USE THEM JUDICIOUSLY IN SPINE DEFORMITY CASES, PREFERABLY ON BONE SURFACE OR IN SOFT TISSUE SPACES. THE AUTHORS RECOMMEND PRIMARY PREVENTION BY METICULOUS PATIENT HISTORY GATHERING ABOUT ALLERGY TO THESE PRODUCTS AND ADVISE CAUTION IF INJECTING THE MATERIAL INTO VASCULAR BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT:: BASED ON THE INFORMATION PROVIDED, THIS PATIENT HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA WAS USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS WERE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. IT WAS NOTED THAT FOLLOWING PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERNS IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTIONS IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE., COMMENT: BASED ON THE INFORMATION PROVIDED, THIS PATIENT HAD A POTENTIAL HISTORY OF ALLERGY TO ANIMAL PROTEIN. THE GELATIN-ACTIVATED THROMBIN MEDIA WAS USED TO CONTROL BLEEDING WHEN PEDICLE SCREWS WERE PLACED. HOWEVER, WHEN THE MEDIA IS INJECTED, THE INCREASE IN PRESSURE OF THE MATERIAL WITHIN THE BONY CAVITY CAN FORCE THE GELATIN INTO THE VENOUS VASCULATURE. IT WAS NOTED THAT FOLLOWING PRESSURIZED INTRAVERTEBRAL ADMINISTRATION OF A TOPICAL HEMOSTATIC AGENT LED TO INTRAOPERATIVE ANAPHYLAXIS. GIVEN THE ONSET OF HEMODYNAMIC INSTABILITY, ORAL-MUCOSAL SWELLING, URTICARIAL RASH AND ELEVATED TRYPTASE, A PRESUMPTIVE DIAGNOSIS OF ANAPHYLAXIS WAS MADE. THESE SUBSTANCES PROVIDE MULTIFACTORIAL RISKS IF THEY ENTER THE SYSTEMIC CIRCULATION. THE GELATIN OR MATRIX ITSELF MAY ALSO ACT AS AN EMBOLUS. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERNS IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTIONS IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248814 | GELFOAM | POWDER, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 MO | Male | Life Threatening| R| O |