BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMORY HERNIA LARGE PATCHES

    MDR report key: 1081418 · Received July 24, 2008

    Report

    Report Number
    MW5007791
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    May 5, 2005
    Report Date
    July 24, 2008
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD TWO HERNIA PATCHES PUT IN ME BY TWO HOSPITALS. THE FIRST ONEI FELT TEAR AWAY FROM ITS SURGERY SITE IN 2005 AND, I HAVE BEEN COMPLAINING EVER SINCE ABOUT IT. I HAD DOWNLOADED YOUR RECALL INFO ON THEM ABOUT THE RECALL. I HAVE BEEN TO ALL THREE HOSPITALS; BUT, I CANNOT GET ANYONE TO READ THE FULL REPORT FROM YOUR OFFICE. ABOUT THE RECALL AND REMOVAL OF ALL SAID PATCHES. I HAVE BEEN TOLD REPEATEDLY THAT WE DON'T USE THAT PATCH OR "NAME BRAND." THE ONE IN THE RIGHT GROIN AREA, I FEEL HAD BEEN ON THE MOVE SINCE THEN UNTIL THIS VERY DAY. I WILL BE AT MEDICAL CENTER TODAY ASKING THEM TO REMOVE IT. IT IS VERY LIKELY THEY WILL NOT REMOVE IT EVEN THOUGH IT IS CAUSING ME PAIN. PAIN FOR WELL OVER THREE YEARS NOW. MY RIGHT LEG IS SWOLLEN AND THE TOES WILL DO THE SAME AT TIMES. I HURT TO USE THE RESTROOM AT TIMES. DOING THE NUMBER 1 OR THE NUMBER 2, MEDICAL CENTER HAS ORDERED A BELT FOR ME, MEDICAL CENTER WANTED TO OPERATE ON MY BACK AND CUT SOME "NERVES". "SO THAT I WOULD NOT FEEL THE PAIN DOWN MY RIGHT LEG." WHEN I ASKED THEM TO OPERATE ON MY BACK AFTER BEING HIT BY A CAR ON MY BIRTHDAY. THEY REFUSE ME AND MANY OTHER VETERANS ANY RELIEF. JUST GAVE US PILLS OR MORE PILLS.." PLEASE HELP ME, BOTH OF MY KNEES JOINTS ARE KILLING ME FROM THE SWELLING AND THE DAMAGE DONE TO THEM WHILE IN THE ARMY FROM 1968 UNTIL 1992. DO NOT KNOW PRODUCT NAME OTHER THAN LARGER PATCH, V.A. WILL NOT GIVE OUT THAT INFO TO ME OR PRINT IT OUT ON MY RECORDS, WHEN ASKED BY ME, OF THEM. DATES OF USE: 2003 - 2008. DIAGNOSIS OR REASON FOR USE: HERNIA REPAIR. HERNIA REPAIR. EVENT REAPPEARED AFTER REINTRODUCTION? YES. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMORY HERNIA LARGE PATCHES NONE FTL
    2 MEMORY HERNIA LARGE PATCHES NONE FTL
    3 BARD PERFIX MESH NONE --- BARD 43HOD140

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R| S