BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM

    MDR report key: 15462941 · Received September 22, 2022

    Report

    Report Number
    1000306051-2022-00155
    Event Type
    Injury
    Date Received
    September 22, 2022
    Date of Event
    February 11, 2016
    Report Date
    September 21, 2022
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. INTERNAL INVESTIGATION INTO STRATTICE LOT SP100069 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 (B)(6) 2022, OF THE 181 DEVICES RELEASED TO FINISHED GOODS FOR LOT SP100069, 170 HAVE BEEN REPORTED AS DISTRIBUTION WITH 112 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 62 YEAR OLD MALE PATIENT HAD A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2014. DURING THE HERNIA REPAIR SURGERY THE SURGEON IMPLANTED A STRATTICE MESH, LOT SP100069-080, CATALOG 2030002. AFTER SURGERY, THE PATIENT HAD A REVISION SURGERY WHICH INCLUDED A RECURRENT VENTRAL HERNIA REPAIR, LYSIS OF EXTENSIVE ADHESIONS AND REPAIR OF SMALL BOWEL OBSTRUCTION ON (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY AN ADDITIONAL STRATTICE MESH WAS IMPLANTED, THE RECORDS INDICATE THIS IS A STRATTICE FIRM; THE LOT NUMBER FOR THAT MESH IS SP100280-022. THE CATALOG IS 220008. THE CATALOG ITEM NUMBER FOR LOT SP100280-022 IS NOT VALID, HOWEVER THE LOT NUMBER IS AND IS ASSOCIATED WITH CATALOG ITEM 2020002. ON (B)(6) 2017, HE HAD SURGERY FOR A RECURRENT VENTRAL HERNIA DUE TO THE FAILED STRATTICE IMPLANTS. THIS RECORD IS ASSOCIATED WITH LOT SP100069-080 IMPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698525 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM MESH, SURGICAL FTM SP100069

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention NO INFORMATION.