BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT

    MDR report key: 1152084 · Received September 7, 2008

    Report

    Report Number
    MW5008233
    Event Type
    Injury
    Date Received
    September 7, 2008
    Date of Event
    June 10, 2008
    Report Date
    September 7, 2008
    Manufacturer
    ETHICON, JOHNSON AND JOHNSON
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A TVT PROCEDURE WITH A GYNECARE SLING IN 2008. WITHIN 4 WEEKS, I SUFFERED MESH EROSION IN THE VAGINA. DATES OF USE: ONGOING. DIAGNOSIS OR REASON FOR USE: STRESS INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE TVT NONE FTL ETHICON, JOHNSON AND JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| S