BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR AND APICAL PROLAPSE REPAIR

    MDR report key: 2842106 · Received November 13, 2012

    Report

    Report Number
    2183959-2012-02995
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    October 16, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT-(B)(4). 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 BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH AN ELEVATE ON OR ABOUT (B)(6) 2009 TREAT PELVIC ORGAN PROLAPSE. IT WAS ALLEGED THE PLAINTIFF HAS SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EXTREME VAGINAL PAIN, EROSION OF INTERNAL BODILY TISSUE, DYSPAREUNIA, AND BLEEDING RESULTING IN ADDITIONAL SURGERIES AND MEDICAL TREATMENT. MANY OF THESE INJURIES ARE PERMANENT IN NATURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S DESARA T SLING SYSTEM - IMPLANTED | SUSPEND FASCIA LATA SYSTEM | DESARA T SLING SYSTEM - IMPLANTED| SUSPEND FASCIA LATA SYSTEM