BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING

    MDR report key: 1132790 · Received August 21, 2008

    Report

    Report Number
    MW5008058
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    October 8, 2007
    Report Date
    August 21, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    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 WAS DIAGNOSED WITH VAGINAL PROLAPSE; HAD NO HISTORY OF URINE LEAKAGE PRIOR TO SURGERY. PRODUCTS USED: AMS' MONARCH SLING AND CALDERA MEDICAL'S POP MESH. UNABLE TO URINATE ON MY OWN AFTER SURGERY; WAS GIVEN MACROBID TO USE TO PREVENT INFECTION UNTIL I WAS ABLE TO VOID MYSELF. THREE WEEKS LATER, I BROKE OUT IN HIVES. AFTER VISITS TO DERMATOLOGIST, AND 4 ROUNDS OF PREDNISONE LATER, THE HIVES DISAPPEARED BUT I WAS LEFT WITH RED AREA ON MY BODY THAT BURNED/ITCHED LIKE PRICKLY HEAT; OTHER AREAS DEVELOPED A "HONEYCOMB" TYPE RED RASH -NOT RAISED-. AS A TEACHER, THE ITCH/BURNING WAS DEBILITATING. I HAVE HAD BLOOD TESTS, URINE TESTS, SKIN PATCH TESTS, CHEST X-RAYS, A CT SCAN ORDERED BY MY INTERNIST -AN ENDOCRINOLOGIST-, MY ALLERGIST, AND MY DERMATOLOGIST. THEY COULD NOT FIGURE OUT THE UNDERLYING CAUSE OF MY CONDITION OR WHAT TO DO FOR IT. I WAS SENT TO THE CLINIC IN 2008, AND BEGAN EXTENSIVE TESTING THERE, INCLUDING A BONE MARROW BIOPSY. THE DERMATOLOGISTS ALL AGREE THAT THIS IS NOT A DERMATOLOGICAL PROBLEM. THERE IS AN UNDERLYING CAUSE FOR THE RASH AND THE HORRIBLE PRICKLY HEAT. THE HEAD OF MY TEAM SAYS THAT ALL OF MY TESTS ARE NORMAL, SAVE A SLIGHTLY ELEVATED WHITE COUNT. THEY AREN'T GOING TO ORDER ANY FURTHER TESTS. I AM LEFT IN THIS CONDITION. IS THERE ANY RECOURSE TO FIND OUT IF ANY ONE ELSE HAS HAD THIS PROBLEM SINCE THE SLING AND MESH WERE USED IN THEIR VAGINA/BLADDER PROLAPSE SURGERY?. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: VAGINAL PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARC SLING MONARC SLING FTL AMERICAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other