BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 2251098 · Received September 8, 2011

    Report

    Report Number
    2183959-2011-00335
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOMES AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, DURING AN ELEVATE-POSTERIOR IMPLANT PROCEDURE, DURING RIGHT SIDED FIXATION, THE RECTUM WAS PERFORATED. THE ENTIRE DEVICE WAS REMOVED AND A POSTERIOR COLPORRHAPHY WAS PERFORMED. A GENERAL SURGEON CLOSED THE RECTAL DEFECT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention