BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL HERNIA PATCH

    MDR report key: 990660 · Received January 26, 2008

    Report

    Report Number
    MW5005162
    Event Type
    Injury
    Date Received
    January 26, 2008
    Date of Event
    November 12, 2007
    Report Date
    January 26, 2008
    Manufacturer
    SURGICAL SENSE, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD HERNIA SURGERY IN 1998, TO REPAIR A -RIGHT SIDE- INGUINAL HERNIA. THE SURGEON IMPLANTED A SMALL OVAL KUGEL MESH PATCH. STARTING IN 2007, I HAD BAD PAIN IN MY ABDOMEN-SO BAD THAT I COULD NOT WORK. AFTER MANY MRIS, CTS, ULTRASOUNDS, AND 2 SURGERIES THE DOCTORS DISCOVERED THAT I HAD A KUGEL FAILURE. IN 2007, I UNDERWENT MY SECOND SURGERY AND THE SURGEON FOUND THAT MY KUGEL MESH HAD BROKEN INSIDE OF ME AND A PIECE OF PLASTIC FROM THE RING WAS PUSHING ON MY INSIDES. THE BROKEN PIECE WAS THE REASON FOR MY PAIN AND IF I HAD CONCEIVED BEFORE HAVING THIS REMOVED THE BROKEN PLASTIC WOULD HAVE BEEN IN THE WAY OF MY UTERUS AS IT GREW. THANKFULLY, THE SURGEON WAS UNABLE TO REMOVE -OR PRY- THIS KUGEL MESH PATCH AWAY FROM MY TISSUE AND MUSCLE. I HAD TO HAVE 3 NERVES DIVIDED, AND HAVE BEEN TOLD THAT I WILL PROBABLY HAVE NERVE PAIN FOREVER. THE KUGEL MESH WAS INSERTED IN 1998. THE INFO IS: SIZE-SMALL OVAL 8X12CM, CAT NO-10-101, LOT NO-041398. DATES OF USE: 1998 - 2007. DIAGNOSIS OR REASON FOR USE: TO REPAIR AN INGUINAL HERNIA -RIGHT SIDE-.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL HERNIA PATCH NONE FTL SURGICAL SENSE, INC. * 041398

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R| S