GELFILM
Report
- Report Number
- 1810189-2019-00012
- Event Type
- Malfunction
- Date Received
- April 24, 2019
- Report Date
- August 28, 2018
- 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
- 003
Narratives
QO HAS RECEIVED THREE COMPLAINTS WITH KNOWN BATCH NUMBERS. OUR ASSESSMENT OF THE DETAILS OF THE COMPLAINT AGAINST OUR MEDICAL DEVICE RISK FILE DETERMINED THAT THE REPORTED MALFUNCTION HAS A WORST CASE SEVERITY RANKING OF S5. FORWARDED THIS "LACK OF EFFECT (LOE)" TO US AS A POTENTIAL PRODUCT COMPLAINT. FINAL REPORT: SUBJECT WAS GELFOAM STERILE OPTHALMIC FILM X 6 -JAPAN, COMPLAINT WAS PRODUCT USE ATTRIBUTES, LACK OF EFFECT. SCOPE: SINCE FURTHER CONFIRMATION OF THE PRODUCT USED COULD NOT BE OBTAINED, AND GELFOAM AND GELFILM SHARE A COMMON BULK SOLUTION, ALL GELFILM, AS WELL AS GELFOAM SPONGE AND POWDER, BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THE REPORTED COMPLAINT WAS DETERMINED TO BE THE ONLY COMPLAINT WITHIN SCOPE. RETURNED PRODUCT EXAMINATION: PGS DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. AN EXAMINATION OF RETAINED REFERENCE SAMPLES COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR UNKNOWN BATCH, AND THERE WERE NO RELATED COMPLAINTS WITH KNOWN BATCHES. IT SHOULD BE NOTED THAT, GIVEN THE COMPLAINT IS IN REGARDS TO PRODUCT EFFICACY, M1 EXAMINATION OF RETAINED REFERENCE SAMPLES WOULD NOT HAVE AIDED IDENTIFICATION OF A ROOT CAUSE. TESTING: WITHOUT A KNOWN BATCH NUMBER IT IS NOT POSSIBLE TO SUBMIT RETAINED REFERENCE SAMPLES TO THE PFIZER QUALITY CONTROL LABORATORY FOR ANALYSIS; HOWEVER, A REVIEW OF STABILITY TESTING DATA FOR GELFILM WAS PERFORMED. ALL GELFILM PRODUCTS WERE ALSO REVIEWED. ALL STABILITY TEST RESULTS WERE WITHIN SPECIFICATION. ADDITIONALLY, A REVIEW OF STABILITY TESTING DATA FOR GELFOAM WAS PERFORMED. ALL GELFOAM SPONGE AND POWDER PRODUCTS WERE ALSO REVIEWED. THERE WERE OUT OF SPECIFICATION (OOS) STABILITY TEST RESULTS FOR THE COMPRESSED GEL FOAM PRESENTATION.
EVENT VERBATIM [PREFERRED TERM] LACK OF EFFECT (LOE) [DEVICE INEFFECTIVE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A NON-CONTACTABLE CONSUMER VIA PRODUCT QUALITY COMPLAINT GROUP. THIS CONSUMER REPORTED SIMILAR EVENTS FOR 3 PATIENTS. THIS IS 1ST OF 3 REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GELFILM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE FOR UNKNOWN INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT EXPERIENCED LACK OF EFFECT (LOE). "QO HAS RECEIVED THREE COMPLAINTS WITH KNOWN BATCH NUMBERS. OUR ASSESSMENT OF THE DETAILS OF THE COMPLAINT AGAINST OUR MEDICAL DEVICE RISK FILE DETERMINED THAT THE REPORTED MALFUNCTION HAS A WORST CASE SEVERITY RANKING OF S5. POTENTIAL HARM TO PATIENT: INADEQUATE OR EXCESSIVE AMOUNT APPLIED, ADVERSE EVENT, DELAY OF SURGERY, INCONVENIENCE. IMPACT TO DEVICE: SLOWED/DELAYED HEALING, ISSUES WITH WOUND DRAINAGE". THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. OUTCOME OF EVENT WAS UNKNOWN. UPON FOLLOW UP ON 26APR2019, FINAL INVESTIGATION REPORT RECEIVED FROM PRODUCT QUALITY COMPLAINTS GROUP. FINAL REPORT: SUBJECT WAS GELFOAM STERILE OPTHALMIC FILM X 6 -JAPAN, COMPLAINT WAS PRODUCT USE ATTRIBUTES, LACK OF EFFECT. SCOPE: SINCE FURTHER CONFIRMATION OF THE PRODUCT USED COULD NOT BE OBTAINED, AND GELFOAM AND GELFILM SHARE A COMMON BULK SOLUTION, ALL GELFILM, AS WELL AS GELFOAM SPONGE AND POWDER, BATCHES PRODUCED WITHIN THE 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE QUERIED WITHIN PCOM, AND ALL COMPLAINTS FOUND WERE EXAMINED AGAINST THE REPORTED COMPLAINT NARRATIVE AND COMPLAINT CLASSIFICATION. THE REPORTED COMPLAINT WAS DETERMINED TO BE THE ONLY COMPLAINT WITHIN SCOPE. RETURNED PRODUCT EXAMINATION: PGS DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. AN EXAMINATION OF RETAINED REFERENCE SAMPLES COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR UNKNOWN BATCH, AND THERE WERE NO RELATED COMPLAINTS WITH KNOWN BATCHES. IT SHOULD BE NOTED THAT, GIVEN THE COMPLAINT IS IN REGARDS TO PRODUCT EFFICACY, M1 EXAMINATION OF RETAINED REFERENCE SAMPLES WOULD NOT HAVE AIDED IDENTIFICATION OF A ROOT CAUSE. TESTING: WITHOUT A KNOWN BATCH NUMBER IT IS NOT POSSIBLE TO SUBMIT RETAINED REFERENCE SAMPLES TO THE PFIZER QUALITY CONTROL LABORATORY FOR ANALYSIS; HOWEVER, A REVIEW OF STABILITY TESTING DATA FOR GELFILM WAS PERFORMED. ALL GELFILM PRODUCTS WERE ALSO REVIEWED. ALL STABILITY TEST RESULTS WERE WITHIN SPECIFICATION. ADDITIONALLY, A REVIEW OF STABILITY TESTING DATA FOR GELFOAM WAS PERFORMED. ALL GELFOAM SPONGE AND POWDER PRODUCTS WERE ALSO REVIEWED. THERE WERE OUT OF SPECIFICATION (OOS) STABILITY TEST RESULTS FOR THE COMPRESSED GEL FOAM PRESENTATION. SEE QAR 1218916 BELOW. DEVIATIONS: COMPLETE -ACCEPTABLE. DEVIATIONS (QUALITY ASSURANCE REPORT - QAR), LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS FOR ALL BATCHES IN ANNUAL PRODUCT REVIEW REPORTS (APRRS) FOR 36 MONTHS PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE REVIEWED. A REVIEW OF EACH INVESTIGATION DETERMINED THAT THERE WAS NO POTENTIAL IMPACT TO THE OVERALL QUALITY OF THE IMPACTED BATCH, AND THAT THE IMPACTED BATCH REMAINS ACCEPTABLE. QAR 905710 WAS COMPLETED DUE TO A HUMIDITY EXCURSION IN THE DRYING TUNNELS FOR TWO BATCHES. THE ROOT CAUSE WAS DETERMINED TO BE EQUIPMENT RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCHES AND THE BATCHES REMAIN ACCEPTABLE. QAR 916465 WAS COMPLETED FOR BATCH 147514 FOR A HIGH AMOUNT OF CRITICAL AND MAJOR DEFECTS IN THE CATEGORY OF SURFACE AIR BUBBLES AND HOLES EXTENDING THROUGH THE SPONGE. ALL DEFECTS WERE REMOVED, AND THE REMAINDER OF THE LOT WAS DETERMINED TO BE ACCEPTABLE FOR RELEASE, AND THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH. QAR 1003904 WAS COMPLETED DUE TO A MIX TIME NOT BEING RECORDED DURING THE MANUFACTURE OF BATCH 146047. THE ROOT CAUSE WAS DETERMINED TO BE HUMAN PERFORMANCE RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. QAR 1054471 WAS COMPLETED FOR A GELFOAM EXTRUSION NITROGEN FILTER THAT DID NOT HAVE A POST-INTEGRITY TEST DUE TO ITS INADVERTENT DISPOSAL. THE ROOT CAUSE WAS DETERMINED TO BE HUMAN PERFORMANCE RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. LIR 1210426 WAS COMPLETED FOR A CONFIRMED OUT-OF-SPECIFICATION (OOS) STABILITY RESULT FOR WATER ABSORPTION OF GELFOAM SPONGE COMPRESSED FOR BATCH J18378. THE ROOT CAUSE OF THE CONFIRMED OOS RESULT WAS FURTHER INVESTIGATED IN QAR 1218916. LIR 1250585 WAS COMPLETED FOR A CONFIRMED OUT-OF-SPECIFICATION (OOS) STABILITY RESULT FOR WATER ABSORPTION OF GELFOAM SPONGE COMPRESSED FOR BATCH 070493. THE ROOT CAUSE OF THE CONFIRMED OOS RESULT WAS FURTHER INVESTIGATED IN QAR 1218916. QAR 1218916 WAS COMPLETED TO INVESTIGATE THE TWO CONFIRMED OOS RESULTS FOR WATER ABSORPTION OF GELFOAM SPONGE COMPRESSED. (SEE LIR 1210426 AND LIR 1250585 ABOVE) INVESTIGATION RESULTED IN REPORT TO FDA OF THE OOS. THE OOS WAS SPECIFIC TO THE COMPRESSED CONFIGURATION OF THE GELFOAM SPONGE. THE INVESTIGATION INTO THE STABILITY FAILURES YIELDED PMA SUPPLEMENT PMA N18- 286/S029/A001. THE FDA HAS APPROVED THE SUPPLEMENT. THE STABILITY STRATEGY OUTLINED IN THE SUPPLEMENT INDICATES THAT OUR COMMITMENT IS TO EVALUATE THE RELATIONSHIP BETWEEN COMPRESSED AND NON-COMPRESSED WATER ABSORPTION OVER THE PRODUCT LIFETIME. BASED ON THIS, THE STABILITY LIMITS FOR COMPRESSED SPONGE WILL BE CHANGED FROM NLT 35X ITS WEIGHT IN WATER TO "REPORT RESULTS". THE CURRENT RELATIONSHIP BETWEEN COMPRESSED AND UNCOMPRESSED WATER ABSORPTION DELINEATED IN THE FAILURES NOTED IN THE INVESTIGATION HAS BEEN DEEMED BY THE FDA TO BE ACCEPTABLE FOR CONTINUED DISTRIBUTION. QAR 1249291 WAS COMPLETED FOR A DATA REPORT THAT INDICATED THAT TRENDING DATA FROZE 15 MINUTES INTO TEMPERATURE REPORTING, AND REPEATED THE SAME RESULTS FOR THE REMAINDER OF THE TIME BATCH L94119 WAS IN THE OVEN. THE ROOT CAUSE WAS DETERMINED TO BE EQUIPMENT RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. QAR 1259209 WAS COMPLETED FOR AN EXTRUSION PUMP FAILURE DURING THE PROCESS OF EXTRUDING GELFOAM BATCH M26964. THE ROOT CAUSE WAS DETERMINED TO BE HUMAN PERFORMANCE RELATED. BRICKS PRODUCED BEFORE THE FAILURE WERE CONSIDERED ACCEPTABLE FOR RELEASE, AND THE REMAINDER OF THE BATCH WAS NOT EXTRUDED AND REJECTED IN PROCESS. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAIN ACCEPTABLE. QAR 1349037 WAS COMPLETED FOR A NITROGEN ADDITION ERROR FOR A JAPAN GELFOAM BATCH. THE ROOT CAUSE WAS DETERMINED TO BE HUMAN PERFORMANCE RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. QAR 1358243 WAS COMPLETED FOR A TEMPERATURE DEVIATION DURING TRANSIT FOR BATCH M57644. THE ROOT CAUSE WAS DETERMINED TO BE ENVIRONMENT RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. QAR 1365060 WAS COMPLETED AS A RESULT OF A COMPLAINT FOR A SPONGE SHOWING APPARENT AGGLOMERATES. THE ROOT CAUSE WAS DETERMINED TO BE EQUIPMENT RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. QAR 1434990 WAS COMPLETED AS A RESULT OF A CUSTOMER COMPLAINT FOR ABNORMAL THICKNESS OF THE PRODUCT. THE ROOT CAUSE WAS DETERMINED TO BE ENVIRONMENT RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. QAR 1475446 WAS COMPLETED FOR A COMPLAINT THAT SPONGES "FEEL AND APPEAR THINNER THAN NORMAL". THE COMPLAINT SAMPLE SPONGES APPEARED TO HAVE NORMAL MINOR COMPRESSION AT THE COMERS OF THE SPONGE THAT IS EXPECTED WITH STORAGE IN THE GELFOAM ENVELOPE. THE ROOT CAUSE WAS DETERMINED TO BE RELATED TO THE ENVIRONMENT AND IT WAS DETERMINED THAT THERE WAS NO IMPACT TO THE OVERALL QUALITY OF THE BATCH. QAR 1505358 WAS COMPLETED FOR WARPING AND SHRINKAGE DEFECTS WERE FOUND DURING RELEASE TESTING OF BATCH N59584. THE ROOT CAUSE WAS DETERMINED TO BE METHOD/PROCEDURE RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. QAR 1562829 WAS COMPLETED FOR A CALCULATION ERROR DURING THE MANUFACTURE OF BATCH Q05355, CAUSING AN INVALID IN-TOLERANCE RESULT. THE ROOT CAUSE WAS DETERMINED TO BE HUMAN PERFORMANCE RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. QAR 1582379 WAS COMPLETED FOR USE OF A 40 GALLON STERILE MANUFACTURING TANK FOR WHICH GELFILM WAS NOT A PART OF THE PRODUCT MATRIX, IMPACTING BATCHES M90917, KL508, R13062, RI 1270, RI 1271, H94239, H94277, R13747, R13748, AND R55748. THE ROOT CAUSE WAS DETERMINED TO BE HUMAN PERFORMANCE RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCHES AND THE BATCHES REMAIN ACCEPTABLE. QAR 1634735 WAS COMPLETED TO DOCUMENT A TEMPERATURE AND HUMIDITY EXCURSION IN THE GELFOAM MANUFACTURING AREA AS A RESULT OF A PLANNED SHUTDOWN OF THE AIR COOLING SYSTEM. THE EFFECT OF THE CHANGE IN TEMPERATURE AND HUMIDITY ON THE IN PROGRESS DRUG PRODUCT WAS CONDUCTED. THE ROOT CAUSE WAS DETERMINED TO BE ENVIRONMENT AND IT WAS DETERMINED THAT THERE WAS NO IMPACT TO THE QUALITY OF EACH AFFECTED BATCH. QAR 1764444 WAS COMPLETED FOR BRICKS CUTTER BLADES SHOWING SIGNS OF WEAR DURING THE PROCESSING OF BATCH S51215. THE ROOT CAUSE WAS DETERMINED TO BE EQUIPMENT RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. QAR 1767513 WAS COMPLETED FOR A COMPLAINT FOR THINNER THAN NORMAL GELFOAM IN BATCH IB489. THE ROOT CAUSE WAS DETERMINED TO BE ENVIRONMENT RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. QAR 1815119 WAS COMPLETED FOR THE BRICK HEIGHT FAILURE PROCESS NOT BEING EXECUTED DURING THE PROCESSING OF BATCH S30866. THE ROOT CAUSE WAS DETERMINED TO BE HUMAN PERFORMANCE RELATED. IT WAS DETERMINED THAT THERE WAS NO IMPACT TO QUALITY OF THE BATCH AND THE BATCH REMAINS ACCEPTABLE. MANUFACTURING AND PACKAGING RECORDS: COMPLETE -ACCEPTABLE. A REVIEW OF APRR RECORDS AS RELATED TO THE MANUFACTURING PROCESS WAS PERFORMED AS A PART OF THIS INVESTIGATION. THE REVIEW OF THE REPORTS DETERMINED THAT NO NEGATIVE QUALITY TRENDS WERE PRESENT. THERE WERE NO RELATED COMPLAINTS TO REVIEW BATCH RECORD INFORMATION. GELFILM: DURING FORMULATION, THE BILL OF MATERIALS WAS COMPARED TO THE IN-PROCESS MATERIAL USAGE REPORT TO ASSURE THAT THE CORRECT RAW MATERIALS AND AMOUNTS WERE USED IN THE MANUFACTURE OF THE LOT. ALL MANUFACTURING MIXING SPEEDS, TIMES, AND TEMPERATURES HAVE SPECIFICATION CRITERIA. THE PRODUCT IS POURED INTO SHEETS WITHIN SPECIFIED PARAMETERS. AFTER THE PRODUCT POURED INTO SHEETS, THE SHEETS ARE INSPECTED FOR COSMETIC AND FOREIGN MATERIAL DEFECTS. NO DEFECTIVE SHEETS WERE NOTED FOR THE REPORTED LOT. AFTER THE SHEETS ARE SLICED INTO INDIVIDUAL FILMS, A 100% VISUAL INSPECTION IS PERFORMED FOR CONSISTENCY, UNIFORMITY, SHAPE, AND SIZE. ALL FILM SAMPLE MEASUREMENTS WERE PERFORMED USING A CALIBRATED MICROMETER AND DOCUMENTED AS ACCEPTABLE. ALL DEFECTIVE FILMS ARE IDENTIFIED AND REMOVED. FURTHERMORE, THE TOTAL NUMBER OF ACCEPTABLE ENVELOPES IS COMPARED TO THE THEORETICAL YIELD, AND THE RESULTS COMPARED TO ACCEPTANCE CRITERIA. THE GELFILM ARE PLACED INTO INNER ENVELOPES AND TRANSFERRED TO THE DOYEN PACKAGING EQUIPMENT TO PACKAGE THE ENVELOPES INTO PEEL POUCHES. THE DOYEN TAKES SIX ENVELOPES PER ROTATION BY SUCTION AND LOADS THEM ONTO A CONVEYER BELT AGAINST AN ALIGNMENT TAB. TWO OPERATORS SIT AT THE DOYEN TO CORRECT ALIGNMENT ISSUES PRIOR TO SEALING. THE FRONT AND BACK PAPERS, WHICH MAKE UP THE OUTER PEEL POUCH, ENCLOSE EACH INDIVIDUAL INNER ENVELOPE ENTIRELY WITH A FOUR-SIDED, HEAT-ACTIVATED ADHESIVE SEAL. THE TOP, BOTTOM, AND SIDES OF THE OUTER PEEL POUCHES ARE SEALED BY THREE DIFFERENT PARTS OF THE DOYEN WHICH EACH HAVE SEPARATE TEMPERATURE CONTROLS. EACH TEMPERATURE CONTROL IS VERIFIED AND DOCUMENTED IN THE BATCH RECORD. THE PEEL POUCHES ARE SEALED AND HEAT STERILIZED. SEALED AND STERILIZED GELFILM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE PEEL POUCHES HAVE THE PROPER APPEARANCE, SEAL AND PRINT. A SEAL INTEGRITY TEST (SIT) IS UTILIZED THROUGHOUT THE FINAL PACKAGING TO ENSURE THE SIDE SEALS OF THE PEEL POUCHES ARE ACCEPTABLE. THE PEEL POUCHES ARE PACKAGED INTO THEIR FINAL GOODS CARTON. 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 OO BATCH HISTORY REPORT: COMPLETE-ACCEPTABLE. AS THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN, A REVIEW OF THE BATCH HISTORY FOR THE COMPLAINT COULD NOT BE PERFORMED. MEDICAL DEVICE TREND ANALYSIS: COMPLETE-ACCEPTABLE. THE COMPLAINT HISTORY FOR GEL FILM AND GELFOAM FOR THE 36 MONTHS PRIOR TO THE RECEIPT DATE OF THE REPORTED COMPLAINT WITH COMPLAINT CLASSIFICATION 'PRODUCT USE ATTRIBUTES' WITH THE SUB-CLASSIFICATIONS OF 'LACK OF EFFECT', 'PERFORMANCE NOT AS INDICATED IN LABEL', AND PRODUCT USE ATTRIBUES DEFECT NOT CLASSIFIED' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. A REVIEW OF COMPLAINTS DATA WITHIN THE APRRS IDENTIFIED NO TREND THAT WOULD REQUIRE FURTHER INVESTIGATIONS, OR NOTIFICATION TO THE MEDICAL DEVICE QOP. ROOT CAUSE: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE PRODUCTION PROCESS. A REVIEW OF THE APRR REPORTS, AND EVALUATION OF TRENDS, INDICATED THAT ALL GELFILM AND GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (PLACE NAME) SITE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, INVESTIGATION REPORTS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORT ABILITY. FURTHER ACTION BY PFIZER IS NOT REQUIRED. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO ALLOW APPROPRIATE REPORTING TO HEALTH AUTHORITIES. EVENT RECODED, NARRATIVE UPDATED. FOLLOW-UP (19APR2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: INDICATION OF GELFILM CONFIRMED AS NOT REPORTED, EVENT TERM AND THE IMPACT TO THE DEVICE UPDATED. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW UP (26APR2019): NEW INFORMATION RECEIVED FROM A PRODUCT QUALITY COMPLAINTS GROUP INCLUDED: FINAL INVESTIGATION REPORT. CASE COMMENT: THIS IS CONSUMER REPORT, AND 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 SERIOUS INJURY (SEVERE POSTOPERATIVE SEQUELAE, SUCH AS SLOWED/DELAYED HEALING, ISSUES WITH WOUND DRAINAGE, PERMANENT CSF LEAKAGE, ETC) TO PATIENT, IF IT WERE TO RECUR, CONSIDERING THE APPROVED INDICATIONS OF ABSORBABLE GELATIN (GELFILM). NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED., COMMENT: THIS IS CONSUMER REPORT, AND 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 SERIOUS INJURY (SEVERE POSTOPERATIVE SEQUELAE, SUCH AS SLOWED/DELAYED HEALING, ISSUES WITH WOUND DRAINAGE, PERMANENT CSF LEAKAGE, ETC) TO PATIENT, IF IT WERE TO RECUR, CONSIDERING THE APPROVED INDICATIONS OF ABSORBABLE GELATIN (GELFILM). NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED.
QO HAS RECEIVED THREE COMPLAINTS WITH KNOWN BATCH NUMBERS. OUR ASSESSMENT OF THE DETAILS OF THE COMPLAINT AGAINST OUR MEDICAL DEVICE RISK FILE DETERMINED THAT THE REPORTED MALFUNCTION HAS A WORST CASE SEVERITY RANKING OF S5. FORWARDED THIS "LACK OF EFFECT (LOE)" TO US AS A POTENTIAL PRODUCT COMPLAINT.
EVENT VERBATIM [PREFERRED TERM] LACK OF EFFECT (LOE) [DEVICE INEFFECTIVE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A NON-CONTACTABLE CONSUMER VIA PRODUCT QUALITY COMPLAINT GROUP. THIS CONSUMER REPORTED SIMILAR EVENTS FOR 3 PATIENTS. THIS IS 1ST OF 3 REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GELFILM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE FOR UNKNOWN INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT EXPERIENCED LACK OF EFFECT (LOE). "QO HAS RECEIVED THREE COMPLAINTS WITH KNOWN BATCH NUMBERS. OUR ASSESSMENT OF THE DETAILS OF THE COMPLAINT AGAINST OUR MEDICAL DEVICE RISK FILE DETERMINED THAT THE REPORTED MALFUNCTION HAS A WORST CASE SEVERITY RANKING OF S5. POTENTIAL HARM TO PATIENT: INADEQUATE OR EXCESSIVE AMOUNT APPLIED, ADVERSE EVENT, DELAY OF SURGERY, INCONVENIENCE. IMPACT TO DEVICE: SLOWED/DELAYED HEALING, ISSUES WITH WOUND DRAINAGE". THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. OUTCOME OF EVENT WAS UNKNOWN. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO ALLOW APPROPRIATE REPORTING TO HEALTH AUTHORITIES. EVENT RECODED, NARRATIVE UPDATED. FOLLOW-UP (19APR2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: INDICATION OF GELFILM CONFIRMED AS NOT REPORTED, EVENT TERM AND THE IMPACT TO THE DEVICE UPDATED. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. COMPANY CLINICAL EVALUATION COMMENT: THIS IS CONSUMER REPORT, AND 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 SERIOUS INJURY (SEVERE POSTOPERATIVE SEQUELAE, SUCH AS SLOWED/DELAYED HEALING, ISSUES WITH WOUND DRAINAGE, PERMANENT CSF LEAKAGE, ETC) TO PATIENT, IF IT WERE TO RECUR, CONSIDERING THE APPROVED INDICATIONS OF ABSORBABLE GELATIN (GELFILM)., COMMENT: THIS IS CONSUMER REPORT, AND 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 SERIOUS INJURY (SEVERE POSTOPERATIVE SEQUELAE, SUCH AS SLOWED/DELAYED HEALING, ISSUES WITH WOUND DRAINAGE, PERMANENT CSF LEAKAGE, ETC) TO PATIENT, IF IT WERE TO RECUR, CONSIDERING THE APPROVED INDICATIONS OF ABSORBABLE GELATIN (GELFILM).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335842 | GELFILM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |