BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT

    MDR report key: 1345996 · Received March 17, 2009

    Report

    Report Number
    MW5010376
    Event Type
    Injury
    Date Received
    March 17, 2009
    Date of Event
    December 28, 2004
    Report Date
    March 17, 2009
    Manufacturer
    JOHNSON AND JOHNSON, ETHICON
    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

    IN 2004, I HAD SURGERY DURING WHICH I HAD A HYSTERECTOMY, BLADDER TACK USING THE TVT TAPE, OVARY REMOVED AND TWO LARGE HERNIAS REPAIRED USING THE MESH. I ENDED UP IN CRITICAL CARE AND IN A NURSING HOME. AN OPEN WOUND REQUIRING 50 FT OF 3 INCH CURLEX TO PACK INTO MY OPEN WOUND. I HAD HOME HEALTH NURSE ON A DAILY BASIS. COMPLETE SEPARATION OF THE SKIN AND MUSCLES OF MY ABDOMINAL WALL. SINCE 2004, I HAVE NOT BEEN ABLE TO WORK DUE TO INFECTIONS IN MY ABDOMINAL WALL. I HAD SURGERY AGAIN IN 2005 TO TRY AND REMOVE SCAR TISSUE IN HOPES OF HEALING. NOW AFTER ALL THESE YEARS OF PAIN, I HAVE SURGERY AGAIN IN 2008 TO HAVE THE HERNIA MESH REMOVED DUE TO ACUTE INFECTION IN MY ABDOMINAL WALL. THEY HAD TO TOTALLY RECONSTRUCT MY WALL DUE TO THE MESH. I AM NOW POST OP ALMOST FIVE MONTHS AND STILL WITH A DRAIN TUBE. I AM HAVING PROBLEMS WITH MY BLADDER DUE TO THE TVT DEVICE USED FOR MY BLADDER SUSPENSION. I AM SEEING A SPECIALIST NOW FOR THAT REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE TVT TVT FTL JOHNSON AND JOHNSON, ETHICON

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| O| R| S PROLENE MESH FOR REPAIR OF A 10 CM VENTRAL HERNIA| AND SMALLER HERNIAS| 3X5 SHEETS