BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT

    MDR report key: 2244014 · Received September 6, 2011

    Report

    Report Number
    MW5022172
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    July 18, 2006
    Report Date
    September 6, 2011
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INCLUDING, BUT NOT LIMITED TO, I HAD A TRANSVAGINAL SLING IMPLANTED (B)(6) 2006. ON (B)(6) 2006, I WENT TO THE EMERGENCY ROOM TO HAVE A CATHETER PUT IN SO I COULD URINATE. ON (B)(6) 2006, I HAD SURGERY TO ADJUST SLING SO I COULD URINATE. STILL EXPERIENCING PAIN, I HAD A HERNIA REPAIRED ON (B)(6) 2007. STILL EXPERIENCING PAIN I HAD EXPLORATORY SURGERY ON (B)(6) 2008. NOTHING FOUND BUT ADHESIONS WHERE MY GALL BLADDER WAS REMOVED. STILL IN PAIN AFTERWARDS. ON (B)(6) 2009, I HAD PART OF SLING REMOVED FROM URETHRA AND HOLES IN URETHRA REPAIRED. STILL IN PAIN I HAD EXPLORATORY SURGERY ON (B)(6) 2010. FOUND TWISTED COLON AND ADHESIONS. HAD BOTH REMOVED. STILL IN PAIN AFTERWARDS. ON (B)(6) 2010, I HAD MORE OF THE SLING REMOVED FROM THE URETHRA AND TWO HOLES IN THE URETHRA REPAIRED. STILL IN PAIN AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE TVT BLADDER SLING FTL JOHNSON & JOHNSON 1323258

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O| R| S