BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM

    MDR report key: 12041781 · Received June 22, 2021

    Report

    Report Number
    1000306051-2021-03016
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    September 13, 2019
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A INVESTIGATION INTO LOT S11050 RESULTED IN NO REMARKABLE FINDINGS AND ONE UNRELATED PROCESSING DEVIATIONS AND ONE UNRELATED NONCONFORMANCE REVEALED. (B)(4) DEVICES RELEASED TO FINISHED GOODS FOR LOT S11050, (B)(4) HAVE BEEN DISTRIBUTED. OF THE (B)(4) DISTRIBUTED, (B)(4) HAVE BEEN REPORTED AS IMPLANTED. ONE OTHER UNRELATED COMPLAINTS AGAINST LOT S11050 WERE REVEALED. LOT S11050 WAS ASEPTICALLY PROCESSED, TERMINALLY STERILIZED AND MET ALL QC RELEASE CRITERIA.

    Description of Event or Problem · 1

    PATIENT REPRESENTATIVE REPORTED A (B)(6) YO MALE PATIENT HAD STRATTICE, 2025002 AND 1010002, IMPLANTED ON (B)(6) 2012 FOR A HERNIA REPAIR. PATIENT HAD A SURGERY ON (B)(6) 2019 FOR A BULGING RE-OCCURRENT HERNIA AND MESH WAS EXPLANTED. LOT NUMBER S11050-239 AND S11075-053. THIS MDR FOR S11050.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936887 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM MESH, SURGICAL FTM S11050

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention