BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 2212463 · Received August 11, 2011

    Report

    Report Number
    2183959-2011-00287
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    IT WAS REPORTED THAT DURING AN ELEVATE ANTERIOR PROCEDURE, BLEEDING OCCURRED IN THE AREA OF THE SACROSPINOUS LIGAMENT AFTER INSERTION OF THE APICAL ARM. THE BLEEDING WAS CONTROLLED BY COMPRESSION. A DRAIN WAS PLACED WHEN CLOSING THE VAGINAL WALL WITH 500 CC OF BLOOD NOTED THE FOLLOWING MORNING. THE PATIENT WAS REPORTED TO BE DOING WELL.

    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 Hospitalization| R