BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 2200873 · Received August 8, 2011

    Report

    Report Number
    2183959-2011-00290
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    March 28, 2011
    Report Date
    July 13, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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

    AN ELEVATE ANTERIOR DEVICE WAS IMPLANTED ON (B)(6) 2009. IT WAS REPORTED THAT A CYSTOCELE RECURRED BECAUSE THE VAGINAL MUCOSA FAILED TO INCORPORATE INTO THE MESH, RESULTING IN THE DESCENT OF THE ANTERIOR WALL. A REVISION PROCEDURE WAS DONE ON (B)(6) 2011.

    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 Required Intervention MONARC| ANAL PLASTY| ELEVATE POSTERIOR