BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM HERNIA REPAIR MESH

    MDR report key: 2103340 · Received May 20, 2011

    Report

    Report Number
    MW5020695
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    March 3, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ATRIUM
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I UNDERWENT LAPAROSCOPIC SURGERY FOR BILATERAL INGUINAL HERNIA REPAIR. THE DR INFORMED ME AFTER THE PROBLEM STARTED THAT THE PRODUCT USED WAS 3 X 6 ATRIUM MESH AND A PROTACK STAPLER. THE REPAIR ON THE LEFT SIDE FAILED AND WITHIN 10 DAYS OF THE SURGERY, THE HERNIA WAS DETECTED AGAIN. I SUBSEQUENTLY UNDERWENT OPEN ABDOMINAL SURGERY TO REPAIR THE HERNIA. I WAS INFORMED THAT THE DEVICE WAS NOT REMOVED. SINCE THE SECOND SURGERY ON MY LEFT SIDE, I HAVE SUFFERED THROUGH SEVERE SWELLING AT THE HERNIA SITE, EXTENDING DOWN TO AND INCLUDING MY SCROTUM WITH CONTINUED PAIN IN THE GROIN AREA AND TESTICLE ON THE SIDE OF THE SURGERY. THE HARD SWELLING HAS PERSISTED FOR ABOUT 3 WEEKS WITH NO DIMINISHING IN SIZE OR IN PAIN. MY SURGEON HAS WITHDRAWN 2 - 3 CC OF BLOODY FLUID 2 TIMES OVER THIS PERIOD. I HAVE HAD CERVICAL FUSION SURGERY, BILATERAL SHOULDER SURGERY, KNEE SURGERY, AND AN APPENDECTOMY OVER THE PAST 10 YEARS WITHOUT ANY PROBLEMS. THERE HAS NEVER BEEN ANY UNEXPECTED SWELLING OR PAIN AND I HEALED COMPLETELY WITHIN A FEW WEEKS. I AM CONVINCED THAT THE MESH IMPLANT OR PROTACK STAPLES WERE DEFECTIVE IN SOME WAY AND MY CONTINUED PROBLEM MUST BE THE RESULT OF THE MESH STILL RESIDING IN MY GROIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIUM HERNIA REPAIR MESH HERNIA REPAIR MESH 3 X 6 FTL ATRIUM 10726114046
    2 PROTACK STAPLER STAPLER GDW TYCO COVIDIEN 174006

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization