BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING

    MDR report key: 2202167 · Received August 4, 2011

    Report

    Report Number
    MW5021677
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    May 10, 2005
    Report Date
    August 4, 2011
    Manufacturer
    AMS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY MONARC MESH SLING WAS IMPLANTED BY DR (B)(6), MD, MBA; (B)(6), SEVERAL YEARS AGO. THE DEVICE DID NOT SOLVE MY SERIOUS URINARY INCONTINENCE. IN FACT, MY SYMPTOMS ARE WORSE AND I HAVE A GREAT DEAL OF PAIN AND DISCOMFORT. I HAVE ALSO HAD SEVERAL URINARY TESTS WHICH SHOWED EVIDENCE OF BLOOD. DR (B)(6) SUGGESTED THAT HE CAN "GO BACK IN" AND TIGHTEN THE SLING, BUT SINCE I LOST MY HEALTH INSURANCE, HE WAS UNWILLING TO DO THE REPAIR. IF YOU HAVE ANY ADVICE AS TO HOW TO MANAGE THIS CLAIM, I WOULD APPRECIATE IT. MANY THANKS, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARC SLING VAGINAL MESH FOR URINARY INCONTINENCE FTL AMS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R