BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM

    MDR report key: 11379832 · Received February 25, 2021

    Report

    Report Number
    1000306051-2021-00013
    Event Type
    Injury
    Date Received
    February 25, 2021
    Date of Event
    February 17, 2019
    Manufacturer
    LIFECELL
    Product Code
    FTM
    UDI-DI
    00818410010140
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QA INVESTIGATION INTO LOT SP100237 RESULTED IN NO REMARKABLE FINDINGS AND NO DEVIATIONS AND NO NONCONFROMANCES REVEALED. 254 DEVICES WERE RELEASED TO FINISHED GOODS AND 187 HAVE BEEN DISTRIBUTED. OF THE 187 DISTRIBUTED, 158 HAVE BEEN REPORTED AS IMPLANTED. LOT SP100237 WAS TERMINALLY STERILIZED AND MET ALL QC RELEASE CRITERIA INCLUDING MECHANICAL TESTING.

    Description of Event or Problem · 0

    PATIENT UNDERWENT SPIGELIAN HERNIA REPAIR SURGERY. SURGEON IMPLANTED STRATTICE MESH (LOT/BATCH: SP100237-231, CATALOG/REFERENCE #: 2020002). APPROXIMATELY 3.5 YEARS LATER,PATIENT RETURNED TO THE HOSPITAL AND WAS DIAGNOSED WITH A SEROMA AND NONINTEGRATED BIOLOGIC ABDOMINAL REINFORCEMENT MATRIX. SURGEON NOTICED THAT THE MESH SPLIT IN HALF REQUIRING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274567 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM MESH, SURGICAL FTM LIFECELL SP100237 00818410010140

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention