BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM

    MDR report key: 16249833 · Received January 26, 2023

    Report

    Report Number
    1000306051-2023-00002
    Event Type
    Injury
    Date Received
    January 26, 2023
    Date of Event
    January 4, 2022
    Report Date
    January 26, 2023
    Manufacturer
    LIFECELL
    Product Code
    FTM
    UDI-DI
    00818410010119
    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 (B)(4) 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 18 JAN 2023, OF THE (B)(4) DEVICES RELEASED TO FINISHED GOODS FOR LOT (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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 48 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2021. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A STRATTICE10 CM X 10 CM HERNIA MESH, LOT NO. (B)(4) REFERENCE NO. 1010002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2021, FOR A REVISION SURGERY AND THE PATIENT WAS IMPLANTED WITH STRATTICE TISSUE MATRIX MESH, LOT NUMBER (B)(4), REFERENCE NO. 1016002. THE MESH FAILED, AND THE PATIENT RETURNED TO THE HOSPITAL FOR A SECOND REVISION SURGERY ON (B)(6) 2022. NO OTHER INFORMATION WAS REPORTED. THIS RECORD IS ASSOCIATED WITH (B)(4) IMPLANTED ON (B)(6) 2021. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR # 1000306051-2023-00001. (ABBVIE COMPLAINT # (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480500 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM MESH, SURGICAL FTM LIFECELL SP200326 00818410010119

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention