BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 2903248 · Received January 2, 2013

    Report

    Report Number
    2183959-2012-03428
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    November 16, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. LAWYER-FILED REPORT: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED "PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE" AND THE "INABILITY TO ENGAGE IN CHOSEN AND NECESSARY ACTIVITIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070 ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability GYNECARE TVT| GYNECARE TVT