BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE ANTERIOR SLING/MESH

    MDR report key: 2142912 · Received June 23, 2011

    Report

    Report Number
    2142912
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    January 3, 2011
    Report Date
    May 18, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONE SIDE OF ELEVATE ANTERIOR REPAIR MESH WOULD NOT SEAT PROPERLY ON THE TISSUE. A SECOND PRODUCT WAS OPENED AND PERFORMED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATE ANTERIOR SLING/MESH PROLAPSE REPAIR SYSTEM FTL AMERICAN MEDICAL SYSTEMS * 683518010

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR