BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM

    MDR report key: 11991981 · Received June 14, 2021

    Report

    Report Number
    1000306051-2021-03007
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    November 14, 2014
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    QA INVESTIGATION INTO LOT S10929 RESULTED IN NO REMARKABLE FINDINGS AND NO DEVIATIONS AND NO NONCONFROMANCES REVEALED. (B)(4) DEVICES WERE RELEASED TO FINISHED GOODS. (B)(4) REPORTED AS IMPLANTED (B)(4) HAVE BEEN DISTRIBUTED. NO OTHER COMPLAINTS AGAINST. LOT S10929 WERE REVEALED. LOT S10929 WAS ASEPTICALLY PROCESSED, TERMINALLY STERILIZED AND MET ALL QC RELEASE CRITERIA.

    Description of Event or Problem · 1

    PATIENT REPRESENTATIVE REPORTED THAT A FEMALE PATIENT HAD STRATTICE IMPLANTED FOR A HERNIA REPAIR ON (B)(6) 2011. ON (B)(6) 2014 SHE HAD ADHESIONS, BOWEL OBSTRUCTION AND AN EXPLANT OF THE STRATTICE. LOT NUMBER S10929-010 CATALOG 2020002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887372 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM MESH, SURGICAL FTM S10929

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention