BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR

    MDR report key: 1615982 · Received February 25, 2010

    Report

    Report Number
    2183959-2009-00147
    Event Type
    Injury
    Date Received
    February 25, 2010
    Date of Event
    March 6, 2009
    Report Date
    March 6, 2009
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO FROM CLINICAL EVENT SUMMARY REPORT STATES THAT A PT WHO WAS IMPLANTED WITH ELEVATE GRAFT ON (B) (6) 2009 AT HER 3 MONTH F/U VISIT, SHE WAS EXPERIENCING WORSENING SUI. NO MEDICAL ACTION WAS TAKEN. ADD'L INFO RECEIVED ON 08/19/2009 INDICATES THAT PT STILL SUFFERS FROM SUI, NO SURGERY IS SCHEDULED. ADD'L INFO RECEIVED ON 11/16/2009 INDICATES THAT PHYSICIAN REPORTED AT 6 MO F/U VISIT, THE PT SUI WAS CONTINUING WITHOUT 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