BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 2212567 · Received August 11, 2011

    Report

    Report Number
    2183959-2011-00295
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 9, 2010
    Report Date
    July 15, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT # 2183959-2011-00294. CLINICAL STUDY: (B)(6). ON (B)(6) 2009, AN ELEVATE ANTERIOR WAS IMPLANTED. IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT EXPERIENCED THE ONSET OF MILD DE NOVO URGE INCONTINENCE TREATED WITH VESICARE AND DETRUSULOL. EVENT STATUS IS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability MINIARC SLING