BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT DEVICE WITH PROLENE TAPE

    MDR report key: 3802563 · Received May 9, 2014

    Report

    Report Number
    2210968-2014-02534
    Event Type
    Injury
    Date Received
    May 9, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282561 TVT DEVICE WITH PROLENE TAPE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. LOT 1021032

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention