BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 2254842 · Received September 13, 2011

    Report

    Report Number
    MW5022269
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    June 23, 2009
    Report Date
    September 13, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TRANSVAGINAL MESH IMPLANT. DIAGNOSIS: PAIN AND INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R