BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOMACH MESH FOR HERNIA REPAIR

    MDR report key: 1274163 · Received December 14, 2008

    Report

    Report Number
    MW5009338
    Event Type
    Injury
    Date Received
    December 14, 2008
    Date of Event
    May 29, 2007
    Report Date
    December 14, 2008
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A HIATAL HERNIA REPAIR AND A MESH WAS INSERTED INTO THE STOMACH. TEN DAYS LATER, I DEVELOPED A STAPH INFECTION WHICH WAS TREATED FOR ONE MONTH. NOW 2008 AND THE FOLLOWING MONTH, I HAVE HAD EMERGENCY SURGERY TO CLEAN OUT INFECTED FLUID AND ABSCESSES FROM THE INCISION. TWO DAYS IN THE HOSPITAL AND SO FAR THREE WEEKS OF HOME CARE OF IV ANTIBIOTICS TWICE A DAY. THIS TIME IT IS MRSA. WHEN AND IF THE INFECTION IS CURED, THE MESH HAS TO BE REMOVED WHICH IS A VERY SERIOUS SURGERY WHICH WILL CAUSE A 14 TO 16 INCH INCISION AND A LONG HOSPITAL STAY. THE WHOLE PROBLEM STARTED WHEN A DR. ACCIDENTLY CUT MY STOMACH DURING BACK SURGERY IN 2006 AND HERNIA FORMED IN THE INCISION. I HAVE BEEN THROUGH PAIN, I AM READY TO GIVE UP; I'M NOT SURE I CAN WITHSTAND ANOTHER SURGERY. KIM CALAHAN. DATES OF USE: 2007. 2008 - STILL IN PROGRESS. DIAGNOSIS OR REASON FOR USE: HIALTAL HERNIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| O| S