BEUDAMED
    FDA Adverse Event Other Summary report: N

    TVTO TAPE

    MDR report key: 5496636 · Received March 9, 2016

    Report

    Report Number
    MW5060871
    Event Type
    Other
    Date Received
    March 9, 2016
    Manufacturer
    ETHICON
    Product Code
    FTL
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE TVTO TAPE (ETHICON) LOT 3365739 DEVICE PLACED ON (B)(6) 2010 FOR STRESS URINARY INCONTINENCE. THE DEVICE HAS FAILED AND BESIDES THE PAIN AND SWELLING IN ABDOMEN, CONSTANT UTI'S, THE INCONTINENCE WAS NEVER ALLEVIATED. I'M NOW IN THE PROCESS OF SEARCHING FOR A CAPABLE SURGEON TO REMOVE THE MESH. I BELIEVE THERE MAY BE SOME NERVES AFFECTED BECAUSE OF CERTAIN TIMES WHEN I LIE DOWN, I GET PAIN IN MY HEAD, AND CHEST, WHICH IS ALLEVIATED WITH RE-POSITIONING. I'M NOT SURE WHAT OTHER INFO YOU MAY NEED, BUT AS I'M IN THE BEGINNING STAGES OF FINDING A SURGEON AND ANSWERS TO THIS PAINFUL LIFE CHANGING SITUATION, I WILL HELP YOU AS I RECEIVED KNOWLEDGE TO HELP OTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147664 TVTO TAPE TVTO TA;E FTL ETHICON 3365739

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR