BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRIO-HERNIA PATCH 12.2X10.5X0.3 CM WITH ABSORBAFIX

    MDR report key: 2003551 · Received February 18, 2011

    Report

    Report Number
    MW5019539
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    May 28, 2009
    Report Date
    February 18, 2011
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A HERNIA AT MY BELLY BUTTON AREA. I HAD SURGERY TO REPAIR THE HERNIA ON (B)(6) 2009. I IMMEDIATELY FELT LIKE SOMETHING WAS TERRIBLY WRONG. I DIDN'T WAIT FOR MY FOLLOW UP VISIT TO GO BACK TO THE DOCTOR. SHE TOLD ME IT WAS TOO SOON AND IT WAS FINE. TO MAKE A LONG STORY SHORT, I WENT BACK TO HER SEVERAL TIMES COMPLAINING ABOUT THE PAIN, SWELLING AND HOW MY IMMUNE SYSTEM WAS LOW BECAUSE I HARDLY EVER GET SICK AND I WAS SICK A LOT AND IN BED A LOT. VERY UNUSUAL FOR ME. I DIDN'T WORK OUT BECAUSE OF HOW I FELT SICK, PAIN, TIRED, NOT WELL FELLING. THE DOCTOR MADE ME FEEL LIKE I WAS IMAGINING THINGS AND THAT MAYBE SOMETHING ELSE WAS WRONG BECAUSE THERE WAS NOTHING WRONG WITH MY HERNIA SURGERY. OVER THE FOLLOWING YEAR, I WENT TO SEVERAL DOCTORS AND HAD SEVERAL TESTS TO TRY TO FIND OUT WHAT WAS WRONG AND EVENTUALLY I ENDED UP BACK IN THE SURGEON'S OFFICE. SHE TRIED TO PUT ME OFF AGAIN AND I LET HER KNOW SHE HAD TO DO SOMETHING BECAUSE I REALLY FELT LIKE I WAS GOING TO DIE IF I DIDN'T FIX WHATEVER WAS WRONG. SHE AGREED TO DO AN EXPLORATORY SURGERY AND TOLD ME THERE, THAT THERE WAS A GOOD CHANCE SHE WOULDN'T FIND ANYTHING. I AGREED TO GO AHEAD BUT SHE MADE ME FEEL LIKE I WAS OVERREACTING ONCE AGAIN. MY SURGERY WAS SUPPOSED TO BE AN HOUR, BUT IT WAS A THREE HOUR SURGERY. I HAD ACUTE CHRONIC INFLAMMATION AND PUS POCKETS. THE HERNIA MESH HAD TO BE REMOVED AND NOW I HAVE NO PROTECTION IN THERE BECAUSE I WAS SO INFECTED SHE DIDN'T PUT ANYTHING BACK IN. IT'S BEEN 2 MONTHS NOW AND I BELIEVE MY INFECTION IS BACK. THE DR WANTS ME TO GIVE IT ANOTHER MONTH OR 6 WEEKS BEFORE SHE CHECKS FOR INFECTION. I ASKED THE DR FOR THE BRAND NAME OF THE DEVICE SHE USED (4 TIMES), BUT SHE NEVER DID TELL ME. SHE SAID IT WASN'T THE DEVICE. SHE SAID FOR SOME REASON, MY BODY JUST DIDN'T LIKE WHAT SHE PUT IN THERE AND IT WOULD OF GOT INFECTED NO MATTER WHAT SHE USED. I HAVE BEEN TRYING TO GET COPIES OF MY RECORDS BUT THEY JUST KEEP SENDING ME A COUPLE PAGES EACH TIME AND I STILL DON'T HAVE THE ONES THAT I REQUESTED. I DID GET A COPY OF THE OPERATING REPORT AND IT SAYS THAT SHE USED A VENTRIO-HERNIA PATCH 12.2X10.5X0.3 CM WITH ABSORBAFIX TACKER. COULD YOU PLEASE TELL ME IF OTHER PEOPLE HAVE HAD PROBLEMS WITH THIS PATCH OR IF ITS BEEN RECALLED? THANK YOU VERY MUCH. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRIO-HERNIA PATCH 12.2X10.5X0.3 CM WITH ABSORBAFIX VENTRIO-HERNIA PATCH FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other