BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELFILM

    MDR report key: 17799940 · Received September 22, 2023

    Report

    Report Number
    1810189-2023-00227
    Event Type
    Injury
    Date Received
    September 22, 2023
    Report Date
    September 12, 2023
    Manufacturer
    PFIZER, INC. (DEVICE)
    Product Code
    LMF
    PMA / PMN Number
    18-286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 23OCT2023 FOR ABSORBABLE GELATIN: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFILM ABSORBABLE MATERIAL WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFILM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. 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. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY.' FOR AN UNKNOWN BATCH OF GELFILM WAS INVESTIGATED.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM]. INDICATION: TYMPANIC PERFORATION [OFF LABEL USE], INDICATION: TYMPANIC PERFORATION [DEVICE USE ISSUE], THERE WERE PERSISTENT PERFORATIONS AT 4 WEEKS IN 5/28 CHILDREN (5/36 EARS, 14%) WITH GELFILM R [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "COLLAGEN MATRIX AS A REPLACEMENT FOR GELFILM R FOR POST-TYMPANOSTOMY TUBE MYRINGOPLASTY", INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY, 2020; VOL:135, PGS:110136, DOI:10.1016/J.IJPORL.2020.110136. A 7-YEAR-OLD PATIENT RECEIVED ABSORBABLE GELATIN (GELFILM), FOR TYMPANIC MEMBRANE PERFORATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "POST-TYMPANOSTOMY TUBE MYRINGOPLASTY" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "INDICATION: TYMPANIC PERFORATION"; THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "THERE WERE PERSISTENT PERFORATIONS AT 4 WEEKS IN 5/28 CHILDREN (5/36 EARS, 14%) WITH GELFILM R". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: OTOSCOPY: UNKNOWN RESULTS; TYMPANOMETRY: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. CLINICAL COURSE: THE AUTHOR COMPARED THE EFFECTIVENESS OF TWO MATERIALS (GELATIN FILM [GELFILM, PHARMACIA AND UPJOHN COMPANY KALAMAZOO, MICHIGAN -A SUBSIDIARY OF PFIZER INC.] AND A COMMERCIAL POROUS GRAFT MATERIAL COMPOSED OF EXTRACELLULAR COLLAGEN MATRIX [BIODESIGN, OTOLOGIC REPAIR GRAFT, COOK MEDICAL, WEST LAFAYETTE, IN]) FOR POST-TYMPANOSTOMY TUBE MYRINGOPLASTY. A COMPUTERIZED COLLECTION OF PATIENT OFFICE NOTES AND OPERATIVE REPORTS WAS QUERIED USING THE MICROSOFT WORD "FIND" FEATURE. THE DATA COLLECTION WAS DONE IN A MANNER THAT PROTECTED PATIENT IDENTITY AND PRIVACY. CHILDREN WHO HAD UNDERGONE GELFILM MYRINGOPLASTY WERE IDENTIFIED USING THE SEARCH TERM "GELFILM". THOSE UNDERGOING COLLAGEN MATRIX MYRINGOPLASTY WERE FOUND USING THE SEARCH TERM "COLLAGEN". ALL SURGERIES WERE PERFORMED UNDER GENERAL ANESTHESIA BY MASK FOLLOWING THE USUAL PROTOCOL FOR TYMPANOSTOMY TUBE INSERTION (IE, WITHOUT A MICROSCOPE DRAPE, STERILE FIELD OR EAR CANAL PREPARATION), BY RESIDENTS SUPERVISED BY A SINGLE SURGEON. GELFILM WAS USED IN ALL SURGERIES PRIOR TO DECEMBER 2018 REGARDLESS OF PATIENT AGE OR DURATION OF INTUBATION. COLLAGEN MATRIX WAS USED IN ALL SURGERIES AFTER JANUARY 2019. TYMPANOSTOMY TUBES WERE REMOVED UNDER GENERAL ANESTHESIA USING A PICK AND CUP FORCEPS. MARGINS OF THE RESULTANT PERFORATION WERE RIMMED AND A PATCH PLACED ON THE LATERAL SURFACE OF THE DRUM TO COVER THE PERFORATION. CHILDREN WERE SEEN AT 4 WEEKS AFTER SURGERY (PATCH MYRINGOPLASTY). SUCCESSFUL CLOSURE WAS DETERMINED BY OTOSCOPY AND TYMPANOMETRY IN ALL CASES. IF A PERFORATION APPEARED CLOSED BUT HAD A LARGE VOLUME TYMPANOGRAM, IT WAS SCORED AS A FAILURE. RESIDUAL PERFORATIONS THAT CLOSED SPONTANEOUSLY ON SUBSEQUENT FOLLOW-UP WERE ALSO SCORED AS FAILURES. SUBSEQUENT RECURRENCE OF MIDDLE EAR DISEASE (ACUTE OTITIS MEDIA, MIDDLE EAR EFFUSION, TYMPANIC RETRACTION) WAS NOTED, BUT NOT SCORED AS A FAILURE OF TECHNIQUE. NONE OF THE CHILDREN IN THIS STUDY HAD A CLEFT PALATE, MIDFACIAL MALFORMATION OR TRISOMY 21. 28 PATIENTS IN THE GELFILM GROUP UNDERWENT UNILATERAL REPAIR (11 LEFT EARS, 10 RIGHT EARS), AND 7 HAD BILATERAL MYRINGOPLASTIES. AT 4 WEEKS AFTER SURGERY, THERE WERE 5 PERSISTENT PERFORATIONS AMONG 28 PATIENTS (18%) (THERE WERE PERSISTENT PERFORATIONS AT 4 WEEKS IN 5/28 CHILDREN (5/36 EARS, 14%) WITH GELFILM). PATIENTS WITH PERSISTENT PERFORATION WERE AGES 3, 3, 6, 7, AND 7 YEARS. CAUSALITY FOR "INDICATION: TYMPANIC PERFORATION" AND "THERE WERE PERSISTENT PERFORATIONS AT 4 WEEKS IN 5/28 CHILDREN (5/36 EARS, 14%) WITH GELFILM R" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 23OCT2023 FOR ABSORBABLE GELATIN: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFILM ABSORBABLE MATERIAL WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFILM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. 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. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY.' FOR AN UNKNOWN BATCH OF GELFILM WAS INVESTIGATED. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (23OCT2023): THIS IS A LITERATURE FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "COLLAGEN MATRIX AS A REPLACEMENT FOR GELFILM R FOR POST-TYMPANOSTOMY TUBE MYRINGOPLASTY", INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY, 2020; VOL:135, PGS:110136, DOI:10.1016/J.IJPORL.2020.110136. UPDATED INFORMATION INCLUDED: INVESTIGATION RESULTS. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE EVENTS OF OFF LABEL USE, DEVICE USE IN UNAPPROVED INDICATION AND THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION ARE ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN AND LISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] INDICATION: TYMPANIC PERFORATION [OFF LABEL USE], INDICATION: TYMPANIC PERFORATION [DEVICE USE ISSUE], THERE WERE PERSISTENT PERFORATIONS AT 4 WEEKS IN 5/28 CHILDREN (5/36 EARS, 14%) WITH GELFILM R [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "COLLAGEN MATRIX AS A REPLACEMENT FOR GELFILM R FOR POST-TYMPANOSTOMY TUBE MYRINGOPLASTY", INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY, 2020; VOL:135, PGS:110136, DOI:10.1016/J.IJPORL.2020.110136. A 7-YEAR-OLD PATIENT RECEIVED ABSORBABLE GELATIN (GELFILM), FOR TYMPANIC MEMBRANE PERFORATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "POST-TYMPANOSTOMY TUBE MYRINGOPLASTY" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "INDICATION: TYMPANIC PERFORATION"; THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "THERE WERE PERSISTENT PERFORATIONS AT 4 WEEKS IN 5/28 CHILDREN (5/36 EARS, 14%) WITH GELFILM R". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: OTOSCOPY: UNKNOWN RESULTS; TYMPANOMETRY: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. CLINICAL COURSE: THE AUTHOR COMPARED THE EFFECTIVENESS OF TWO MATERIALS (GELATIN FILM [GELFILM, PHARMACIA AND UPJOHN COMPANY KALAMAZOO, MICHIGAN -A SUBSIDIARY OF PFIZER INC.] AND A COMMERCIAL POROUS GRAFT MATERIAL COMPOSED OF EXTRACELLULAR COLLAGEN MATRIX [BIODESIGN, OTOLOGIC REPAIR GRAFT, COOK MEDICAL, WEST LAFAYETTE, IN]) FOR POST-TYMPANOSTOMY TUBE MYRINGOPLASTY. A COMPUTERIZED COLLECTION OF PATIENT OFFICE NOTES AND OPERATIVE REPORTS WAS QUERIED USING THE MICROSOFT WORD "FIND" FEATURE. THE DATA COLLECTION WAS DONE IN A MANNER THAT PROTECTED PATIENT IDENTITY AND PRIVACY. CHILDREN WHO HAD UNDERGONE GELFILM MYRINGOPLASTY WERE IDENTIFIED USING THE SEARCH TERM "GELFILM". THOSE UNDERGOING COLLAGEN MATRIX MYRINGOPLASTY WERE FOUND USING THE SEARCH TERM "COLLAGEN". ALL SURGERIES WERE PERFORMED UNDER GENERAL ANESTHESIA BY MASK FOLLOWING THE USUAL PROTOCOL FOR TYMPANOSTOMY TUBE INSERTION (IE, WITHOUT A MICROSCOPE DRAPE, STERILE FIELD OR EAR CANAL PREPARATION), BY RESIDENTS SUPERVISED BY A SINGLE SURGEON. GELFILM WAS USED IN ALL SURGERIES PRIOR TO DECEMBER 2018 REGARDLESS OF PATIENT AGE OR DURATION OF INTUBATION. COLLAGEN MATRIX WAS USED IN ALL SURGERIES AFTER JANUARY 2019. TYMPANOSTOMY TUBES WERE REMOVED UNDER GENERAL ANESTHESIA USING A PICK AND CUP FORCEPS. MARGINS OF THE RESULTANT PERFORATION WERE RIMMED AND A PATCH PLACED ON THE LATERAL SURFACE OF THE DRUM TO COVER THE PERFORATION. CHILDREN WERE SEEN AT 4 WEEKS AFTER SURGERY (PATCH MYRINGOPLASTY). SUCCESSFUL CLOSURE WAS DETERMINED BY OTOSCOPY AND TYMPANOMETRY IN ALL CASES. IF A PERFORATION APPEARED CLOSED BUT HAD A LARGE VOLUME TYMPANOGRAM, IT WAS SCORED AS A FAILURE. RESIDUAL PERFORATIONS THAT CLOSED SPONTANEOUSLY ON SUBSEQUENT FOLLOW-UP WERE ALSO SCORED AS FAILURES. SUBSEQUENT RECURRENCE OF MIDDLE EAR DISEASE (ACUTE OTITIS MEDIA, MIDDLE EAR EFFUSION, TYMPANIC RETRACTION) WAS NOTED, BUT NOT SCORED AS A FAILURE OF TECHNIQUE. NONE OF THE CHILDREN IN THIS STUDY HAD A CLEFT PALATE, MIDFACIAL MALFORMATION OR TRISOMY 21. 28 PATIENTS IN THE GELFILM GROUP UNDERWENT UNILATERAL REPAIR (11 LEFT EARS, 10 RIGHT EARS), AND 7 HAD BILATERAL MYRINGOPLASTIES. AT 4 WEEKS AFTER SURGERY, THERE WERE 5 PERSISTENT PERFORATIONS AMONG 28 PATIENTS (18%) (THERE WERE PERSISTENT PERFORATIONS AT 4 WEEKS IN 5/28 CHILDREN (5/36 EARS, 14%) WITH GELFILM). PATIENTS WITH PERSISTENT PERFORATION WERE AGES 3, 3, 6, 7, AND 7 YEARS. CAUSALITY FOR "INDICATION: TYMPANIC PERFORATION" AND "THERE WERE PERSISTENT PERFORATIONS AT 4 WEEKS IN 5/28 CHILDREN (5/36 EARS, 14%) WITH GELFILM R" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE EVENTS OF OFF LABEL USE, DEVICE USE IN UNAPPROVED INDICATION AND THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION ARE ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN AND LISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872408 GELFILM FILM, STERILE; CLASS III LMF PFIZER, INC. (DEVICE)

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Unknown Other| R