BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 3781515 · Received April 30, 2014

    Report

    Report Number
    MW5035828
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 28, 2011
    Report Date
    April 15, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MESH ERODED THROUGH VAGINA, CHRONIC INFLAMMATION , BRAIN FOG, PAIN IN HIPS/ GROIN / LEGS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260956 MONARC SLING SYSTEM OTN AMERICAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 48.000 YR Life Threatening| O| S