BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVAGINAL MESH

    MDR report key: 3022791 · Received March 26, 2013

    Report

    Report Number
    MW5029477
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    June 27, 2005
    Report Date
    March 26, 2013
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED SHE IS TIRED OF BEING INCONTINENT, WEARING DIAPERS, LEAKING WHEN SHE LAUGHS, HAVING SEXUAL PAIN AND LOWER EXTREMITY PAIN. MESH WAS PLACED BY DR (B)(6) AT (B)(6) HOSPITAL IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124014 TRANSVAGINAL MESH TRANSVAGINAL MESH FTL JOHNSON AND JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR