BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIWRAP

    MDR report key: 9664970 · Received February 4, 2020

    Report

    Report Number
    3004661493-2019-00001
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    November 4, 2019
    Report Date
    December 2, 2019
    Manufacturer
    MAST BIOSURGERY USA, INC.
    Product Code
    FTL
    PMA / PMN Number
    K050332
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    RECEIVED NOVEMBER 4TH: SURGIWRAP WAS PLACED DURING LAVH APPROXIMATELY 6 MONTHS AGO. AFTER SHE LEFT THE HOSPITAL, SHE HAD PAIN AND VAGINAL BLEEDING. ON REOPERATION, THE SURGEON SAID THAT HALF OF THE SW PIECES WERE FOUND AND HALF DEGRADED AND YOU CAN SEE THAT THE WOUND ( PRESUMING VAGINAL CUFF) WAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127646 SURGIWRAP MESH, SURGICAL, POLYMERIC FTL MAST BIOSURGERY USA, INC. SURGIWRAP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other