BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM

    MDR report key: 16085953 · Received January 3, 2023

    Report

    Report Number
    1000306051-2022-00216
    Event Type
    Injury
    Date Received
    January 3, 2023
    Date of Event
    July 13, 2017
    Report Date
    January 17, 2023
    Product Code
    FTM
    UDI-DI
    00818410010096
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. THE INTERNAL INVESTIGATION IS PENDING AND WILL BE REPORTED IN A FOLLOW UP REPORT ALONG WITH THE INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATION INTO STRATTICE LOT SP100388 INCLUDED A REVIEW OF THE REPORTED INFORMATION, REVIEW OF THE DEVICE HISTORY RECORDS, AND A REVIEW OF THE COMPLAINT HISTORY RECORDS. THE INVESTIGATION RESULTED IN NO REMARKABLE FINDINGS, INCLUDING NO OTHER COMPLAINTS REPORTED AGAINST THE LOT AND NO DEVIATIONS OR RELATED NON-CONFORMANCES REVEALED DURING PROCESSING. THE LOT WAS TERMINALLY STERILIZED WITHIN THE PROCESS PARAMETERS AND MET ALL QC RELEASE CRITERIA. AS OF 12/JAN/2023, OF THE (B)(4) DEVICES RELEASED TO FINISHED GOODS FOR LOT SP100388, (B)(4) HAVE BEEN DISTRIBUTED WITH (B)(4) REPORTED AS IMPLANTED. BASED ON OUR INTERNAL INVESTIGATION WITH NO REMARKABLE FINDINGS, AND WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE STRATTICE AND THIS EVENT COULD NOT BE DETERMINED. DUE TO THE LEGAL PROCESS, IF ADDITIONAL INFORMATION IS MADE AVAILABLE DURING LEGAL PROCEEDINGS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AS REPORTED IN THE INITIAL: THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. THE INTERNAL INVESTIGATION IS PENDING AND WILL BE REPORTED IN A FOLLOW UP REPORT ALONG WITH THE INVESTIGATION CONCLUSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 62 YEAR OLD FEMALE PATIENT HAD PARASTOMAL HERNIA REPAIR SURGERY ON (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY, PLAINTIFF¿S SURGEON IMPLANTED A STRATTICE MESH IN HER; THE LOT AND BATCH NUMBERS FOR THAT MESH ARE (B)(4). THE CATALOG AND SERIAL NUMBERS FOR THAT MESH ARE 1010002. AFTER SURGERY, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2017. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THIS IS FOLLOW UP#1 TO REPORT THE RESULTS FROM THE INTERNAL INVESTIGATION AND THE CONCLUSION. THE AWARE DATE OF JANUARY 12, 2023 IS BASED ON WHEN THE BATCH RECORD REVIEW WAS COMPLETED. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 62 YEAR OLD FEMALE PATIENT HAD PARASTOMAL HERNIA REPAIR SURGERY ON (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY, PLAINTIFF¿S SURGEON IMPLANTED A STRATTICE MESH IN HER; THE LOT AND BATCH NUMBERS FOR THAT MESH ARE SP100388-147. THE CATALOG AND SERIAL NUMBERS FOR THAT MESH ARE (B)(6). AFTER SURGERY, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2017. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139268 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL FTM SP100388 00818410010096

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention