BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE

    MDR report key: 1220917 · Received November 4, 2008

    Report

    Report Number
    MW5008878
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    July 21, 2005
    Report Date
    November 4, 2008
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD A TVT- O GYNECARE DEVICE IMPLANTED IN 2005, UPON AWAKENING IN RECOVERY HAD EXTREME PAIN IN RIGHT GROIN AREA WHERE DEVICE IS EXITING MY RIGHT LEG. HAVE BEEN POKED PRONGED AND USED AS A GUINEA PIG FOR 3 YEARS NOW TO NO AVAIL, SAME EXTREME PAIN. I HAVE HAD 4 REVISIONS OF THE DEVICE TO NO AVAIL. I HAVE BEEN TOLD I HAVE PERMANENT DAMAGE TO THE RIGHT LEG. IT HURTS WHEN I STAND, SIT, WALK, DRIVE, HAVE SEX, SWIM, USE STAIRS. RUNNING IS COMPLETELY OUT OF THE QUESTIONS AS TO BIKE RIDING NOW I CAN'T DO EITHER NEVER AGAIN! I HAVE BEEN TOLD THAT THEY BELIEVE THE DEVICE WAS EXITED AT THE WRONG ANGLE IN THAT LEG AND I HAVE BEEN TOLD THAT THE DEVICE WASN'T PROPERLY RESEARCHED AND THAT IT IS DEFECTIVE. THE DEVICE WAS SUPPOSED TO BE ABLE TO STRETCH SAFELY AND GO THROUGH TENDONS. I HAVE A REPORT FROM A TEXTILE ENGINEER THAT RESEARCHED THIS DEVICE AND SAYS THAT IT IS DEFECTIVE! WHEN STRETCHED THE DEVICE UNRAVELS AT THE EDGES CAUSING PENETRATION IN THE BODY WHETHER IT BE ORGANS, MUSCLE, TENDON OR WHAT EVER IS IN THE DEVICE'S WAY. I HAVE BEEN TOLD THAT THERE IS A DOCTOR IN TN THAT CAN REMOVE THIS OUT OF MY TENDON AREA IN MY LEG BUT THE RECOVERY TIME IS 1 YEAR BEFORE I CAN WALK AGAIN. UNFORTUNATELY I DIDN'T KNOW THAT THE DEVICE WAS DEFECTIVE UNTIL RECENTLY. IF I HAD KNOWN I WOULDN'T HAVE LET MEDICAL CENTER PLACE ANOTHER GYNECARE DEVICE INSIDE OF ME, IN APRIL OF THIS YEAR, IN WHICH I AM HAVING PAIN WITH IT AS WELL. SO, YES I HAVE TWO DEVICES IN ME THAT ARE DEFECTIVE AND NO INSURANCE NOW TO GET THEM REMOVED! DIAGNOSIS OR REASON FOR USE: INCONTINENCE. PHYSICAL THERAPY FROM 2005 THRU 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE TVT SLING MESH FTL JOHNSON & JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R