BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR

    MDR report key: 1515456 · Received October 22, 2009

    Report

    Report Number
    2183959-2009-00088
    Event Type
    Injury
    Date Received
    October 22, 2009
    Date of Event
    June 23, 2009
    Report Date
    October 22, 2009
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WHO WAS IMPLANTED WITH ELEVATE GRAFT REPORTED VOIDING DYSFUNCTION RESULTING IN SELF CATHETERIZATION AND INTERMITTENT VOIDING. ADD'L INFO RECEIVED ON 10/21/2009 INDICATES THAT PT HAD A REVISION IN 2009, THE MESH WAS LOOSENED SLIGHTLY, SHE CONTINUED TO SELF-CATHETERIZE TWO TO THREE TIMES DAILY. IT WAS RESOLVED FIVE MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATE ANTERIOR SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. 720093-01 590955022

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Life Threatening| R