BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL HERNIA PATCH

    MDR report key: 966138 · Received December 12, 2007

    Report

    Report Number
    MW5004683
    Event Type
    Injury
    Date Received
    December 12, 2007
    Date of Event
    September 15, 2005
    Report Date
    December 12, 2007
    Manufacturer
    SURGICAL SENCE INC. WHICH WAS BOUGHT OUT BY BARD
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2000, I HAD A HERNIA REPAIR THE DR PUT IN A KUGEL PATCH SMALL CIRCLE 8X8CM CAT NO10-103 LOT NO 031000. THEN IN 2005, I EXPERIENCED SEVERE PAIN IN MY BELLY BUTTON ALSO BLEEDING OUT OF MY BELLY BUTTON, I WENT TO THE DR AND SHE BROUGHT DOWN A SURGICAL DR, AND HE TOLD ME MY COLON WAS TWISTED AND THE KUGEL PATCH WAS SEVERELY INFECTED. I HAD TO HAVE SURGERY TO HAVE KUGEL PATCH REMOVED. AFTER THE SURGERY, I EXPERIENCED SEVERE PAIN, I HAD TO CARRY A WOUND VAC AROUND AT ALL TIMES AND A NURSE HAD TO COME TO MY HOME EVERY THREE DAYS AND DIG IN MY OPEN STOMACH AND CLEAN IT OUT, AND BANDAGE THE WOUND. IT WAS VERY PAINFUL. I HAVE NO BELLY BUTTON NOW, AND FOR THE LAST TWO YEARS, I HAVE IRRITABLE BOWEL SYNDROME AND FISTULAS BECAUSE OF THE KUGEL PATCH AND I SUFFER EVERYDAY JUST TO GO TO THE BATHROOM. THIS HAS AFFECTED MY EMOTIONS, AND I GO TO A LICENSED PSYCHOLOGIST TWICE A MONTH PLUS I GO TO MY DR. EVERY MONTH FOR TWO YEARS. I HAVE MANY BILLS, BECAUSE OF THIS AND THE PAIN I HAVE ENDURED IS A LOT FOR ME TO HANDLE AND IS A DAILY EXPERIENCED. DATES OF USE: 2000 - 2005. DIAGNOSIS OR REASON FOR USE: HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL HERNIA PATCH KUGEL PATCH FTL SURGICAL SENCE INC. WHICH WAS BOUGHT OUT BY BARD * 031000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R ON GOING MONTHLY SINCE