BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERNIA MESH

    MDR report key: 1960997 · Received January 10, 2011

    Report

    Report Number
    MW5018964
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 10, 2011
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN ABDOMINAL HERNIA SURGERY A YEAR AGO. IT WAS REPAIRED WITH A MESH. IMMEDIATELY FOLLOWING SURGERY I WAS IN SEVERE PAIN. MY DOCTOR KEPT TELLING ME IT TAKES TIME. I ALSO HAD A LARGER LUMP ON MY STOMACH THAN BEFORE MY HERNIA SURGERY. I WENT BACK TO MY DOCTOR SEVERAL TIMES BUT SHE ALWAYS MADE ME FEEL LIKE I WAS MAKING A BIG DEAL OUT OF NOTHING. I EVENTUALLY THOUGHT MAYBE IT WAS SOMETHING ELSE THAT WAS HURTING ME SO I STARTED GOING TO A STOMACH DOCTOR, A COLON DOCTOR, ETC. EACH DOCTOR DID SOME KIND OF TEST ON ME THAT NOTHING SHOWED UP ON. I ALSO WAS IN SO MUCH PAIN THAT I WENT TO THE EMERGENCY ROOM FOR THE FIRST TIME IN MY LIFE AND THEY DID A CAT SCAN WHICH NOTHING SHOWED UP ON IT. EVENTUALLY I ENDED UP BACK WHERE I STARTED A YEAR LATER. DURING THIS YEAR I WAS IN A LOT OF PAIN AND WAS SICK ALL THE TIME. I AM NORMALLY A VERY HEALTHY PERSON THAT RARELY EVEN CATCHES A COLD. EVERY SINGLE TIME I WAS AROUND MY GRANDCHILDREN I WOULD GET SICK FOR A WEEK. I JUST WAS NOT WELL AND I WAS HURT. I WENT BACK TO THE PERSON THAT DID MY HERNIA SURGERY AGAIN AND I TOLD HER YOU HAVE TO HELP ME, I DON¿T KNOW WHAT ELSE TO DO. SHE TOLD ME THAT SHE WOULD DO AN EXPLORATORY TYPE SURGERY AND IF SHE SAW A NEW HERNIA SHE WOULD REPAIR IT BUT SHE ALSO TOLD ME THAT THERE WAS A GOOD CHANGE SHE WOULD NOT FIND ANYTHING SO I WORRIED THAT MAYBE I SHOULDN'T DO IT. I DECIDED I HAD TO TAKE A CHANCE BECAUSE I COULDN'T KEEP FEELING THIS BAD. I WAS TOLD THE SURGERY WOULD BE ABOUT AN HOUR AND IT ENDED UP BEING OVER 3 HOURS. IT'S BEEN TWO WEEKS AND I STILL DON'T KNOW WHAT HAPPENED. I WENT IN TO GET THE DRAIN TUBE OUT AND THE DR WAS NOT THERE AND NO ONE KNEW WHAT HAPPENED AND I CALLED TO TRY TO FIND OUT AND THEY SAID I HAVE TO TALK WITH THE DR. SO I HAVE AN APPT IN 3 WEEKS AND I WILL TRY TO FIND OUT. ALL SHE TOLD MY HUSBAND WAS THAT IT WAS A LOT MORE WORK THAN SHE THOUGHT AND THAT I HAD A HUGE INFECTION. SO, THAT'S ALL I KNOW. I'M HOPING SHE TOOK THE MESH OUT BECAUSE EVER SINCE I GOT IT I'M HURT AND I AM SICK. I ACTUALLY FEEL LIKE I HAVE SOMETHING THAT IS GOING TO MAKE ME DIE. THAT¿S HOW BAD I FEEL ALL THE TIME. I AM HOPING THAT SHE TOOK OUT THE MESH AND DIDN'T PUT ANY MESH BACK IN BUT AT THIS POINT I DON¿T KNOW AND I DON¿T KNOW WHAT KIND OF MESH WAS PUT IN THE FIRST TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERNIA MESH FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization