BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT-0

    MDR report key: 3901848 · Received June 23, 2014

    Report

    Report Number
    MW5036882
    Event Type
    Injury
    Date Received
    June 23, 2014
    Report Date
    June 22, 2014
    Manufacturer
    GYNECARE
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TVT-O SLING IMPLANTED FOR SUI IN 2010. NUMEROUS VAGINAL "BACTERIAL" INFECTIONS, MESH EROSION, DYSPAREUNIA, 2 PARTIAL MESH REMOVALS AND STILL NEED MORE MESH REMOVED. INCREASED DEPRESSION, ANXIETY, WEIGHT GAIN DUE TO INACTIVITY BECAUSE OF PAIN, UNABLE TO CLIMB STAIRS, PELVIC/HIP/GROIN PAIN. MUSCLE SPASMS, BLADDER SPASMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366827 TVT-0 MESH OTN GYNECARE 810081L 3374632

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| O| R| S