BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR

    MDR report key: 1615980 · Received February 25, 2010

    Report

    Report Number
    2183959-2009-00184
    Event Type
    Injury
    Date Received
    February 25, 2010
    Date of Event
    February 1, 2009
    Report Date
    February 1, 2009
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED FROM CLINICAL EVENT SUMMARY REPORT INDICATES THAT A PT WAS IMPLANTED WITH ELEVATE ON (B) (6) 2009, AT HER 3 MO. F/U VISIT WAS EXPERIENCING SUI. AT HER 6 MO THE SUI WAS RESOLVED WITH NO INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM FTL AMERICAN MEDICAL SYSTEMS, INC. 720093-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability