GEL-FLOW NT
Report
- Report Number
- 1810189-2019-00044
- Event Type
- Malfunction
- Date Received
- June 13, 2019
- Report Date
- June 3, 2019
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHARMACIST
Narratives
23-JUL-2019. QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH: AG1206, EXP 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH: 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH: X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH: 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH: X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. SEVERITY OF HARM S4; FAILURE MODE: REASONABLY SUGGEST DEVICE MALFUNCTION. RELATED LOT NUMBERS: 632893, 632894, 632895, X43308. HAZARDOUS SITUATION: GELFOAM SPONGE DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS. HAZARD NUMBER: H05-01. QO BATCH HISTORY REPORT: COMPLETE ¿ ACCEPTABLE. THE RESULTS OF ALL TESTS AND INSPECTIONS MET REQUIRED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION ON 27NOV2018. RESERVE SAMPLE EVALUATION: RESERVE SAMPLE EVALUATION COMPLETED (GMT): 06JUN2019. VISUAL RESERVE SAMPLE EVALUATION DESCRIPTION: ACCEPTABLE. PFIZER STATE NAME QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH: AG1206, EXP 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH: 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH: X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH: 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH: X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. A BLACK PARTICLE WAS OBSERVED IN ONE GEL-FLOW NT POUCH FOR BATCH: 632894. A FIBER WAS OBSERVED IN TWO GEL-FLOW NT POUCHES FOR BATCH: 632893. BATCH SPECIFIC TREND REVIEW: COMPLETE.
THE EVENT OF "PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING" WAS MAPPED TO HAZARD H05-01 "PRODUCT DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS" WITH WORST SEVERITY LEVEL S4. P2 VALUE FOR A SEVERITY OF S4: 0.0526. THE EXAMINATION OF RETAINED REFERENCE SAMPLES DETERMINED THAT NO FURTHER CONTAINMENT ACTION IS REQUIRED. NO PRODUCT QUALITY DEFECTS WERE OBSERVED.
23-JUL-2019. QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH AG1206, EXP 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS.SEVERITY OF HARM S4; FAILURE MODE: REASONABLY SUGGEST DEVICE MALFUNCTION. RELATED LOT NUMBERS: 632893, 632894, 632895, X43308. HAZARDOUS SITUATION: GELFOAM SPONGE DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS. HAZARD NUMBER: H05-01. QO BATCH HISTORY REPORT: COMPLETE ¿ ACCEPTABLE. THE RESULTS OF ALL TESTS AND INSPECTIONS MET REQUIRED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION ON 27NOV2018. RESERVE SAMPLE EVALUATION: RESERVE SAMPLE EVALUATION COMPLETED (GMT): 06JUN2019. VISUAL RESERVE SAMPLE EVALUATION DESCRIPTION: - ACCEPTABLE. PFIZER STATE NAME QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH AG1206, EXP 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. A BLACK PARTICLE WAS OBSERVED IN ONE GEL-FLOW NT POUCH FOR BATCH 632894. A FIBER WAS OBSERVED IN TWO GEL-FLOW NT POUCHES FOR BATCH 632893. BATCH SPECIFIC TREND REVIEW: COMPLETE.
HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING [DEVICE INEFFECTIVE]. CASE NARRATIVE: THIS IS SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA A PFIZER SALES REPRESENTATIVE. THIS PHARMACIST REPORTED THE SAME EVENT FOR TWO PATIENTS. THIS IS THE 2ND OF THE TWO REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GEL-FLOW NT, NDC NUMBER: 0009-2250-01, LOT NUMBER: AG1206, EXPIRATION DATE: 31MAR2020), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION, ON AN UNSPECIFIED DATE, AT UNKNOWN DOSE, FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHARMACIST REPORTED THAT HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK, "THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING," BUT HE WOULD NOT GIVE ANY DETAILS. THE ACTION TAKEN WITH ABSORBABLE GELATIN AND THE PATIENT OUTCOME WAS UNKNOWN. THE PFIZER SALES REPRESENTATIVE PROVIDED THE REFERENCE#: (B)(4). ON 06JUN2019, THE FOLLOWING WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP: A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SITE NAME REDACTED) WITH REASONABLE MALFUNCTION WITH AN ASSOCIATED WORST-CASE SEVERITY THAT IS UNKNOWN. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. HAZARDOUS SITUATION: UNKNOWN; HAZARD NUMBER: UNKNOWN; P2 VALUES: UNKNOWN. THE PRODUCT QUALITY COMPLAINTS GROUP ADDITIONALLY REPORTED THAT RETAINED REFERENCE SAMPLES WERE EXAMINED AS A PART OF CONTAINMENT. THE EXAMINATION OF RETAINED REFERENCE SAMPLES DETERMINED THAT NO FURTHER CONTAINMENT ACTION IS REQUIRED. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. AN INVESTIGATION WILL BE PERFORMED. THE EVENT OF "PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING" WAS MAPPED TO HAZARD H05-01 "PRODUCT DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS" WITH WORST SEVERITY LEVEL S4. P2 VALUE FOR A SEVERITY OF S4: 0.0526. ON 23JUL2019, ADDITIONAL INFORMATION WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP (PFIZER COMPLAINT NUMBER: (B)(4) AS FOLLOWS: PFIZER SALES REPRESENTATIVE STATED, "I WAS SPEAKING TO A DOCTOR PHARMACY AT ONE OF MY HOSPITALS AND HE MENTIONED TO ME ABOUT HOW OUR GEL-FLOW PRODUCT, HE HAD SEE THAT FROM ONE OF THE NEUROSURGEON SAID THAT IT DID NOT STOP BLEEDING IN ONE OF HIS CASES. I DO NOT HAVE A LOT OF DETAILS ABOUT THE PRODUCT. I DO NOT KNOW WHAT KIND OF CASE, WHAT HIS EXPERIENCE WAS?" PURCHASE DETAILS: PFIZER SALES REPRESENTATIVE STATED, "IT WAS EITHER PURCHASED DIRECTLY FOR PFIZER OR IT WAS FROM THEIR WHOLESALER WHICH I BELIEVE IS WHOLESALER NAME." PFIZER SALES REPRESENTATIVE STATED, "THE OTHER THING THAT HE (THE PHARMACIST) MENTIONED THAT HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING, BUT HE WOULD NOT GIVE ME ANY DETAILS WHOM WE TALK TO THERE. ALL HE SAID WAS THAT IT WAS CLOSE TO HIM. HE DID NOT GET ME ANY KIND OF SPECIFIC, AS A SALES REP. I HAVE TO MAKE SURE THAT, I HAVE A RESPONSIBILITY AND HE WAS NOT COMFORTABLE IN GIVING ME THAT INFORMATION THAT IS ALL I HAVE." THE CLASS/SUB CLASS WAS REPORTED AS PRODUCT USE, LOT NUMBER: AG1206, COMPLAINT CLASS: ATTRIBUTES; COMPLAINT SUBCLASS: /LACK OF EFFECT. BATCH EXPIRY MONTH/YEAR: MAR2020. PFIZER (SITE NAME REDACTED) QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH: AG1206, EXP 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH: 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH: X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH: 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH: X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. SEVERITY OF HARM S4; FAILURE MODE: REASONABLY SUGGEST DEVICE MALFUNCTION. RELATED LOT NUMBERS: 632893, 632894, 632895, X43308. HAZARDOUS SITUATION: GELFOAM SPONGE DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS. HAZARD NUMBER: H05-01. QO BATCH HISTORY REPORT: COMPLETE - ACCEPTABLE. THE RESULTS OF ALL TESTS AND INSPECTIONS MET REQUIRED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION ON 27NOV2018. RESERVE SAMPLE EVALUATION: RESERVE SAMPLE EVALUATION COMPLETED (GMT): 06JUN2019. VISUAL RESERVE SAMPLE EVALUATION DESCRIPTION: ACCEPTABLE. PFIZER STATE NAME QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH: AG1206, EXP 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH: 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH: X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH: 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH: X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. A BLACK PARTICLE WAS OBSERVED IN ONE GEL-FLOW NT POUCH FOR BATCH: 632894. A FIBER WAS OBSERVED IN TWO GEL-FLOW NT POUCHES FOR BATCH: 632893. BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH HISTORY FOR GELFOAM BATCH: AG1206 WITH COMPLAINT CLASSIFICATION 'PRODUCT USE ATTRIBUTES' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. AS OF 07JUN2019, A TOTAL OF ONE COMPLAINT HAS BEEN RECEIVED FOR THIS BATCH NUMBER AND CLASSIFICATION. NO BATCH SPECIFIC TREND WAS IDENTIFIED. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR ALL ABSORBABLE MATERIAL - POWDER PRODUCT CATEGORY COMPLAINTS RECEIVED CLASSIFIED AS 'PRODUCT USE ATTRIBUTES; WAS EVALUATED FOR POTENTIAL TRENDS. THE FOLLOWING PARAMETERS WERE USED PRODUCT CATEGORY: ABSORBABLE MATERIAL - POWDER. TIME PERIOD: 06JUN2016 - 05JUN2019. THE RESULTS OF THE ABOVE QUERY WERE FURTHER EVALUATED BY DATE CONTACTED, AND THEN ALSO BY THE CLASSIFICATION 'PRODUCT USE ATTRIBUTES' AND SUB-CLASSIFICATION OF 'LACK OF EFFECT.' THE REPORTED COMPLAINT IS THE SOLE COMPLAINT THAT HAS BEEN RECEIVED FOR THIS CLASS AND SUB-CLASS. NO NEGATIVE TREND IN REGARDS TO PRODUCT QUALITY WAS IDENTIFIED. MEDICAL DEVICE COMPONENT TREND REVIEW: COMPLETE - ACCEPTABLE. A REVIEW OF COMPLAINTS RECEIVED WITH THE COMPLAINT CLASSIFICATION 'PRODUCT USE ATTRIBUTES' WAS PERFORMED FOR ALL BATCHES MANUFACTURED WITH THE SAME GEL-FLOW NT AND THROMBIN JMI KITS AS A PART OF THIS INVESTIGATION. A TOTAL OF ONE COMPLAINT HAS BEEN RECEIVED FOR THIS CLASSIFICATION RELATED TO PRODUCT MANUFACTURED WITH THE INVOLVED COMPONENT BATCHES. NO COMPONENT SPECIFIC TREND WAS IDENTIFIED. ROOT CAUSE: PFIZER (LOCATION REDACTED) QUALITY OPERATIONS COULD NOT DETERMINE A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT RELATED TO THE (LOCATION REDACTED) PRODUCTION PROCESS OF THE REPORTED BATCH. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN THE IDENTIFICATION OF A ROOT CAUSE. REVIEWED RETAINED REFERENCE SAMPLES WERE ACCEPTABLE IN APPEARANCE. A REVIEW OF ALL OTHER RECORDS, INCLUDING MANUFACTURING RECORDS AND QUALITY INSPECTIONS, FOR THIS PRODUCT INDICATED THAT THIS BATCH HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE LOCATION REDACTED) SITE. QUALITY OF BATCH: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4; THEREFORE, A THE DETAILS OF THE REPORTED COMPLAINT WERE FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (SITE LOCATION REDACTED) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIVE/ PREVENTATIVE ACTION: PFIZER (SITE NAME REDACTED) QUALITY OPERATIONS AND PRODUCTION HAVE BEEN NOTIFIED WITH THE DETAILS OF THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE HAVE BEEN IDENTIFIED AS A RESULT OF THIS INVESTIGATION AT THIS TIME. THE RESULTS OF ALL TESTS, INSPECTIONS, AND IN-PROCESS CONTROLS HAVE BEEN REVIEWED AND ALL RESULTS MET THE ESTABLISHED REQUIREMENTS PRIOR TO THE RELEASE OF THE REPORTED BATCH FOR DISTRIBUTION. CONCLUSION: THE REVIEW OF ALL RECORDS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT WAS S4; THEREFORE PFIZER US SAFETY WAS NOT NOTIFIED FOR EVALUATION OF REGULATORY REPORTABILITY. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE PGS (LOCATION REDATED) MDCP TEAM FOR EVALUATION. TIMEFRAME WITHIN SCOPE. THE WORST CASE SEVERITY FOR THE REPORTED MALFUNCTION DETERMINED FROM RISK. FOLLOW-UP (06JUN2019): THIS IS A FOLLOW-UP SPONTANEOUS REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINT INCLUDED: NOTIFICATION COMPLAINT RECEIVED. FOLLOW-UP (13JUN2019 AND 15JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: HAZARD NUMBER, SEVERITY LEVEL, P2 VALUE. FOLLOW-UP (18JUL2019): NEW INFORMATION REPORTED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES: INFORMATION REGARDING THE EXAMINATION OF RETAINED REFERENCE SAMPLES. FOLLOW-UP (23JUL2019): THIS IS A FOLLOW-UP SPONTANEOUS REPORT FROM PRODUCT QUALITY COMPLAINTS: INVESTIGATION RESULTS SUMMARY. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION., COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED.
EVENT VERBATIM [PREFERRED TERM] HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING [DEVICE INEFFECTIVE]. CASE NARRATIVE: THIS IS SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA A PFIZER SALES REPRESENTATIVE. THIS PHARMACIST REPORTED THE SAME EVENT FOR TWO PATIENTS. THIS IS THE 2ND OF THE TWO REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GEL-FLOW NT, NDC NUMBER: (B)(4), LOT NUMBER: AG1206, EXPIRATION DATE: 31MAR2020), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION, ON AN UNSPECIFIED DATE, AT UNKNOWN DOSE, FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHARMACIST REPORTED THAT HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING, BUT HE WOULD NOT GIVE ANY DETAILS. THE ACTION TAKEN WITH ABSORBABLE GELATIN AND THE PATIENT OUTCOME WAS UNKNOWN. THE PFIZER SALES REPRESENTATIVE PROVIDED THE REFERENCE #: (B)(4). ON 06JUN2019, THE FOLLOWING WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP: A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SITE NAME READACTED) WITH REASONABLE MALFUNCTION WITH AN ASSOCIATED WORST-CASE SEVERITY THAT IS UNKNOWN. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. HAZARDOUS SITUATION: UNKNOWN; HAZARD NUMBER: UNKNOWN; P2 VALUES: UNKNOWN. THE PRODUCT QUALITY COMPLAINTS GROUP ADDITIONALLY REPORTED THAT RETAINED REFERENCE SAMPLES WERE EXAMINED AS A PART OF CONTAINMENT. THE EXAMINATION OF RETAINED REFERENCE SAMPLES DETERMINED THAT NO FURTHER CONTAINMENT ACTION IS REQUIRED. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. AN INVESTIGATION WILL BE PERFORMED. THE EVENT OF "PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING" WAS MAPPED TO HAZARD H05-01 "PRODUCT DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS" WITH WORST SEVERITY LEVEL S4. P2 VALUE FOR A SEVERITY OF S4: 0.0526. FOLLOW-UP (06JUN2019): THIS IS A FOLLOW-UP SPONTANEOUS REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINT INCLUDED: NOTIFICATION COMPLAINT RECEIVED. FOLLOW-UP (13JUN2019 AND 15JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: HAZARD NUMBER, SEVERITY LEVEL, P2 VALUE. FOLLOW-UP (18JUL2019): NEW INFORMATION REPORTED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES: INFORMATION REGARDING THE EXAMINATION OF RETAINED REFERENCE SAMPLES. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION., COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED.
EVENT VERBATIM [PREFERRED TERM] HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING IT DID NOT STOP BLEEDING [DEVICE INEFFECTIVE] , CASE NARRATIVE:THIS IS SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA PFIZER SALES REPRESENTATIVE. THIS PHARMACIST REPORTED SAME EVENT FOR TWO PATIENTS, THIS IS THE 2ND OF THE TWO REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GEL-FLOW NT) (NDC NUMBER: (B)(4), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHARMACIST REPORTED THAT HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING, BUT HE WOULD NOT GIVE ANY DETAILS. THE ACTION TAKEN WITH ABSORBABLE GELATIN AND THE PATIENT OUTCOME WAS UNKNOWN. THE PFIZER SALES REPRESENTATIVE PROVIDED THE REFERENCE (B)(4). ON (B)(6) 2019, THE FOLLOWING WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP: A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SITE NAME READACTED) WITH REASONABLE MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY THAT IS UNKNOWN. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. HAZARDOUS SITUATION: UNKNOWN; HAZARD NUMBER: UNKNOWN; P2 VALUES: UNKNOWN. ON FOLLOW-UP, THE PRODUCT QUALITY COMPLAINTS GROUP PROVIDED ADDITIONAL INFORMATION: THE EVENT OF "PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING" WAS MAPPED TO HAZARD H05-01 "PRODUCT DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS" WITH WORST SEVERITY LEVEL S4. P2 VALUE FOR A SEVERITY OF S4: 0.0526. FOLLOW-UP (B)(6)2019): THIS IS A FOLLOW-UP SPONTANEOUS REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINT INCLUDED: NOTIFICATION COMPLAINT RECEIVED. FOLLOW-UP (B)(6) 2019, NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: HAZARD NUMBER, SEVERITY LEVEL, P2 VALUE. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION, COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED.
EVENT VERBATIM [PREFERRED TERM] HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING [DEVICE INEFFECTIVE] , . CASE NARRATIVE:THIS IS SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA A PFIZER SALES REPRESENTATIVE. THIS PHARMACIST REPORTED THE SAME EVENT FOR TWO PATIENTS. THIS IS THE 2ND OF THE TWO REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GEL-FLOW NT, NDC NUMBER: 0009-2250-01, LOT NUMBER: AG1206, EXPIRATION DATE: 31MAR2020), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION, ON AN UNSPECIFIED DATE, AT UNKNOWN DOSE, FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHARMACIST REPORTED THAT HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK, "THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING," BUT HE WOULD NOT GIVE ANY DETAILS. THE ACTION TAKEN WITH ABSORBABLE GELATIN AND THE PATIENT OUTCOME WAS UNKNOWN. THE PFIZER SALES REPRESENTATIVE PROVIDED THE REFERENCE #Z4UHB1NJ. PGS QO LOCATION DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE FOR EXAMINATION. ON (B)(6)2019, THE FOLLOWING WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP: A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SITE NAME REDACTED) WITH REASONABLE MALFUNCTION WITH AN ASSOCIATED WORST-CASE SEVERITY THAT IS UNKNOWN. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. HAZARDOUS SITUATION: UNKNOWN; HAZARD NUMBER: UNKNOWN; P2 VALUES: UNKNOWN. THE PRODUCT QUALITY COMPLAINTS GROUP ADDITIONALLY REPORTED THAT RETAINED REFERENCE SAMPLES WERE EXAMINED AS A PART OF CONTAINMENT. THE EXAMINATION OF RETAINED REFERENCE SAMPLES DETERMINED THAT NO FURTHER CONTAINMENT ACTION IS REQUIRED. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. AN INVESTIGATION WILL BE PERFORMED. THE EVENT OF "PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING" WAS MAPPED TO HAZARD H05-01 "PRODUCT DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS" WITH WORST SEVERITY LEVEL S4. P2 VALUE FOR A SEVERITY OF S4: 0.0526. ON (B)(6)2019, ADDITIONAL INFORMATION WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP (PFIZER COMPLAINT NUMBER: 4058133) AS FOLLOWS: PFIZER SALES REPRESENTATIVE STATED, "I WAS SPEAKING TO A DOCTOR PHARMACY AT ONE OF MY HOSPITALS AND HE MENTIONED TO ME ABOUT HOWOUR GEL-FLOW PRODUCT, HE HAD SEEN THAT FROM ONE OF THE NEUROSURGEON SAID THAT IT DID NOT STOP BLEEDING IN ONE OF HIS CASES...I DO NOT HAVE A LOT OF DETAILS ABOUT THE PRODUCT. I DO NOT KNOW WHAT KIND OF CASE, WHAT HIS EXPERIENCE WAS?" PURCHASE DETAILS: PFIZER SALES REPRESENTATIVE STATED, "IT WAS EITHER PURCHASED DIRECTLY FOR PFIZER OR IT WAS FROM THEIR WHOLESALER WHICH I BELIEVE IS WHOLESALER NAME." PFIZER SALES REPRESENTATIVE STATED, "THE OTHER THING THAT HE (THE PHARMACIST) MENTIONED THAT HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING, BUT HE WOULD NOT GIVE ME ANY DETAILS WHOM WE TALK TO THERE. ALL HE SAID WAS THAT IT WAS CLOSE TO HIM. HE DID NOT GET ME ANY KIND OF SPECIFIC, AS A SALES REP. I HAVE TO MAKE SURE THAT, I HAVE A RESPONSIBILITY AND HE WAS NOT COMFORTABLE IN GIVING ME THAT INFORMATION THAT IS ALL I HAVE." THE CLASS/SUB CLASS WAS REPORTED AS PRODUCT USE, LOT NUMBER AG1206, COMPLAINT CLASS: ATTRIBUTES; COMPLAINT SUBCLASS: /LACK OF EFFECT. BATCH EXPIRY MONTH/YEAR: MAR2020. PFIZER (SITE NAME REDACTED) QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH AG1206, EXP 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS.SEVERITY OF HARM S4; FAILURE MODE: REASONABLY SUGGEST DEVICE MALFUNCTION. RELATED LOT NUMBERS: 632893, 632894, 632895, X43308. HAZARDOUS SITUATION: GELFOAM SPONGE DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS. HAZARD NUMBER: H05-01. QO BATCH HISTORY REPORT: COMPLETE - ACCEPTABLE. THE RESULTS OF ALL TESTS AND INSPECTIONS MET REQUIRED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION ON 27NOV2018. RESERVE SAMPLE EVALUATION: RESERVE SAMPLE EVALUATION COMPLETED (GMT): 06JUN2019. VISUAL RESERVE SAMPLE EVALUATION DESCRIPTION: - ACCEPTABLE. PFIZER STATE NAME QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH AG1206, EXP 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. A BLACK PARTICLE WAS OBSERVED IN ONE GEL-FLOW NT POUCH FOR BATCH 632894. A FIBER WAS OBSERVED IN TWO GEL-FLOW NT POUCHES FOR BATCH 632893. BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH HISTORY FOR GELFOAM BATCH AG1206 WITH COMPLAINT CLASSIFICATION 'PRODUCT USE ATTRIBUTES' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. AS OF 07JUN2019, A TOTAL OF ONE COMPLAINT HAS BEEN RECEIVED FOR THIS BATCH NUMBER AND CLASSIFICATION. NO BATCH SPECIFIC TREND WAS IDENTIFIED. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR ALL ABSORBABLE MATERIAL - POWDER PRODUCT CATEGORY COMPLAINTS RECEIVED CLASSIFIED AS 'PRODUCT USE ATTRIBUTES; WAS EVALUATED FOR POTENTIAL TRENDS. THE FOLLOWING PARAMETERS WERE USED PRODUCT CATEGORY: ABSORBABLE MATERIAL - POWDER. TIME PERIOD: 06JUN2016 - 05JUN2019. THE RESULTS OF THE ABOVE QUERY WERE FURTHER EVALUATED BY DATE CONTACTED, AND THEN ALSO BY THE CLASSIFICATION 'PRODUCT USE ATTRIBUTES' AND SUB-CLASSIFICATION OF 'LACK OF EFFECT.' THE REPORTED COMPLAINT IS THE SOLE COMPLAINT THAT HAS BEEN RECEIVED FOR THIS CLASS AND SUB-CLASS. NO NEGATIVE TREND IN REGARDS TO PRODUCT QUALITY WAS IDENTIFIED. MEDICAL DEVICE COMPONENT TREND REVIEW: COMPLETE - ACCEPTABLE. A REVIEW OF COMPLAINTS RECEIVED WITH THE COMPLAINT CLASSIFICATION 'PRODUCT USE ATTRIBUTES' WAS PERFORMED FOR ALL BATCHES MANUFACTURED WITH THE SAME GEL-FLOW NT AND THROMBIN JMI KITS AS A PART OF THIS INVESTIGATION. A TOTAL OF ONE COMPLAINT HAS BEEN RECEIVED FOR THIS CLASSIFICATION RELATED TO PRODUCT MANUFACTURED WITH THE INVOLVED COMPONENT BATCHES. NO COMPONENT SPECIFIC TREND WAS IDENTIFIED. ROOT CAUSE: PFIZER (LOCATION REDACTED) QUALITY OPERATIONS COULD NOT DETERMINE A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT RELATED TO THE (LOCATION REDACTED) PRODUCTION PROCESS OF THE REPORTED BATCH. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN THE IDENTIFICATION OF A ROOT CAUSE. REVIEWED RETAINED REFERENCE SAMPLES WERE ACCEPTABLE IN APPEARANCE. A REVIEW OF ALL OTHER RECORDS, INCLUDING MANUFACTURING RECORDS AND QUALITY INSPECTIONS, FOR THIS PRODUCT INDICATED THAT THIS BATCH HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE LOCATION REDACTED) SITE. QUALITY OF BATCH: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4; THEREFORE, A THE DETAILS OF THE REPORTED COMPLAINT WERE FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (SITE LOCATION REDACTED) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIVE/ PREVENTATIVE ACTION: PFIZER (SITE NAME REDACTED) QUALITY OPERATIONS AND PRODUCTION HAVE BEEN NOTIFIED WITH THE DETAILS OF THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE HAVE BEEN IDENTIFIED AS A RESULT OF THIS INVESTIGATION AT THIS TIME. THE RESULTS OF ALL TESTS, INSPECTIONS, AND IN-PROCESS CONTROLS HAVE BEEN REVIEWED AND ALL RESULTS MET THE ESTABLISHED REQUIREMENTS PRIOR TO THE RELEASE OF THE REPORTED BATCH FOR DISTRIBUTION. CONCLUSION: THE REVIEW OF ALL RECORDS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT WAS S4; THEREFORE PFIZER US SAFETY WAS NOT NOTIFIED FOR EVALUATION OF REGULATORY REPORTABILITY. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE PGS (LOCATION REDATED) MDCP TEAM FOR EVALUATION. TIMEFRAME WITHIN SCOPE. THE WORST CASE SEVERITY FOR THE REPORTED MALFUNCTION DETERMINED FROM RISK. SUMMARY OF INVESTIGATION AND CONCLUSION AS OF 08OCT2019: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT USED GEL-FLOW PRODUCT TO STOP BLEEDING POST A SURGICAL PROCEDURE BUT THE PRODUCT WAS INEFFECTIVE AND THE PATIENT CONTINUED TO BLEED. FOLLOW-UP (06JUN2019): THIS IS A FOLLOW-UP SPONTANEOUS REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINT INCLUDED: NOTIFICATION COMPLAINT RECEIVED. FOLLOW-UP (13JUN2019 AND 15JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: HAZARD NUMBER, SEVERITY LEVEL, P2 VALUE. FOLLOW-UP (18JUL2019): NEW INFORMATION REPORTED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES: INFORMATION REGARDING THE EXAMINATION OF RETAINED REFERENCE SAMPLES. FOLLOW-UP (23JUL2019): THIS IS A FOLLOW-UP SPONTANEOUS REPORT FROM PRODUCT QUALITY COMPLAINTS: INVESTIGATION RESULTS SUMMARY. FOLLOW-UP (12AUG2019): FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (08OCT2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: MANUFACTURING SITE DID NOT RECEIVE SAMPLE AND UPDATED CONCLUSION. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. THE FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION.
EVENT VERBATIM [PREFERRED TERM] HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING [DEVICE INEFFECTIVE]. CASE NARRATIVE: THIS IS SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA PFIZER SALES REPRESENTATIVE. THIS PHARMACIST REPORTED SAME EVENT FOR TWO PATIENTS, THIS IS THE 2ND OF THE TWO REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GEL-FLOW NT) (NDC NUMBER: (B)(4)), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHARMACIST MENTIONED THAT HE TALKED TO ANOTHER SURGICAL CENTER WHO HAD THE SAME FEEDBACK THAT THE PRODUCT DID NOT WORK TO STOP BLEEDING, BUT HE WOULD NOT GIVE ANY DETAILS. THE ACTION TAKEN AND OUTCOME WAS UNKNOWN. PFIZER SALES REPRESENTATIVE PROVIDED THE REFERENCE #: (B)(4). COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR., COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 491758 | GEL-FLOW NT | POWDER, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) | AG1206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |