BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC

    MDR report key: 1192246 · Received October 7, 2008

    Report

    Report Number
    MW5008585
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    April 15, 2008
    Report Date
    October 7, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN AMERICAN MEDICAL SYSTEMS' MINIARC BLADDER SLING WAS IMPLANTED IN PT IN 2008. PT HAD PAIN, CAUSED BY THE SLING. ON APPROX FIVE MONTHS LATER, THE SLING HAD TO BE REMOVED, BECAUSE IT WAS FRIABLE WITH PARTS EMBEDDED IN THE PT'S FLESH AND URETHRA. PT LOST HALF OF HER URETHRA AND IS MOST LIKELY GOING TO NEED RECONSTRUCTIVE SURGERY AT THE HOSP. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: STRESS INCONTINENCE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIARC BLADDER SLING FTL AMERICAN MEDICAL SYSTEMS 541840021

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R