BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 885275 · Received July 23, 2007

    Report

    Report Number
    MW5003137
    Event Type
    Injury
    Date Received
    July 23, 2007
    Date of Event
    November 29, 2005
    Report Date
    July 23, 2007
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HI, I HAD A PROLENE HERNIA SYSTEM USED ON A RIGHT INGUINAL HERNIA REPAIR. PHS MESH MANUFACTURER IS ETHICON. SINCE SURGERY, IT FEELS LIKE I'M BEING STABBED IN THE GROIN. WALKING, STANDING MORE THAN A COUPLE MINUTES, RUNNING AND THE LIST GOES ON ARE THINGS I CAN NO LONGER DO. I HAVE NOT WORKED FOR MORE THAN A YEAR AND HAVE BEEN FINANCIALLY RUINED. I TAKE MORPHINE, OXYCONTIN, VALIUM & VICODIN. IT HELPS VERY LITTLE CONSIDERING I USED TO BE A VIBRANT "GET UP AND GO" KIND OF PERSON. I LIVE MORE LIKE A HERMIT AND SOMETIMES "ZOMBIE" WHEN THE PAIN GETS UNBEARABLE. I HAVE BEEN TO A PAIN MANAGEMENT CENTER, WHERE I HAD FOUR RIGHT GENITOFEMORAL NERVE BLOCK SHOTS. OVER A SPAN OF TWO WEEKS. STILL NO RELIEF AND IN FACT MADE THE PAIN WORSE. PLEASE LOOK INTO THIS TYPE OF MESH BEING USED, THERE IS A REASON FOR THIS PAIN I AM SUFFERING AND NO ONE SEEMS TO HAVE ANY ANSWERS. PLEASE HELP. THANK YOU. DATES OF USE: 2005 - 2007. DIAGNOSIS OR REASON FOR USE:HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON HERNIA MESH FTL JOHNSON AND JOHNSON 13186-06

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention PHS HERNIA MESH REPAIR