BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT SECURE

    MDR report key: 2598481 · Received March 10, 2009

    Report

    Report Number
    2598481
    Event Type
    Malfunction
    Date Received
    March 10, 2009
    Date of Event
    February 26, 2009
    Report Date
    March 9, 2009
    Manufacturer
    GYNE CARE / ETHICON J & J CO.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TVT DEVICE FAILURE; SURGEON STATED IT WAS DEFECTIVE "DID NOT RELEASE BOTH SIDES". HE ALSO STATED THIS HAS HAPPENED BEFORE (NOT AT THIS FACILITY). MFR HAS BEEN NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE TVT SECURE TVT TENSION FREE VAGINAL TAPING FTL GYNE CARE / ETHICON J & J CO. 3146838

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other