BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR

    MDR report key: 2172691 · Received July 19, 2011

    Report

    Report Number
    2183959-2011-00265
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 15, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    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

    RELATED TO MFR REPORT 32183959-2011-00264. ON (B)(6) 2011, AN ELEVATE ANTERIOR WAS IMPLANTED WITH SACRAL SPINOUS FIXATION TO TREAT SYMPTOMATIC CYSTOCELE, PELVIC ORGAN PROLAPSE AND VAGINAL VAULT PROLAPSE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT HAD PERSISTENT MINIMAL VAGINAL DISCHARGE "EMANATING" FROM SMALL POINTS OF MESH EROSION. ON (B)(6) 2011 THE PATIENT UNDERWENT "EXTIRPATION OF SMALL AMOUNTS OF ERODED MESH" AT THE 3, 6 AND 9 O'CLOCK POSITIONS. THE MUCOSA WAS OVER-SOWN IN EACH AREA. THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention MINIARC