BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL COMPOSIX MESH PATCH

    MDR report key: 1213584 · Received October 28, 2008

    Report

    Report Number
    MW5008789
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    August 10, 2007
    Report Date
    October 16, 2008
    Manufacturer
    *
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS HAVING TROUBLE WITH MY STOMACH, SO THEY DID TEST AND FOUND THAT I HAD A LOT OF INFECTION IN MY STOMACH. THAT'S WHEN THEY DID THE SURGERY IN 2007. I WAS ADMITTED ON A WEEK EARLIER. THE MESH WAS INFECTED WHICH HAD GROWN INTO MY SMALL BOWEL. THEY HAD TO RESECT APPROXIMATELY 2 FEET OF MY SMALL BOWEL. SO I ENDED UP WITH A WOUND VAC. I ALSO HAD TO HAVE HOME HEALTH COME IN AND TAKE CARE OF MY WOUND. I ENDED UP GOING BACK TO THE HOSPITAL WITH AN INFECTION IN MY STOMACH AGAIN. IT MADE ME EVEN MORE DEPRESSED BECAUSE I COULDN'T DO ANYTHING BECAUSE OF THE WOUND VAC. I WAS ESPECIALLY DEPRESSED BECAUSE WHAT IT DID TO MY STOMACH. I FEEL WORSE ABOUT MY STOMACH NOW. DATES OF USE; FROM 2006 TO 2007. DIAGNOSIS OR REASON FOR USE: INFECTION MESH WITH SMALL BOWEL FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL COMPOSIX MESH PATCH NONE FTL * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R| S WOUND VAC. HAD TO WEAR FOR AROUND 6 WEEKS.