BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE PROLAPSE REPAIR SYSTEM

    MDR report key: 2852345 · Received November 27, 2012

    Report

    Report Number
    2183959-2012-03021
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    February 19, 2011
    Report Date
    October 19, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    REFER TO MFR REPORT # 2183959-2012-03020. IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH AN ELEVATE MESH PRODUCT ON OR ABOUT (B)(6) 2010, TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. IT WAS ALLEGED THE PLAINTIFF SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EXTREME AND CHRONIC PAIN, EROSION OF HER INTERNAL BODILY TISSUE, WORSENING DYSPAREUNIA, SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HARDENING, RECURRENT INCONTINENCE, AND PERMANENT INJURY. ON OR ABOUT (B)(6) 2011, THE PLAINTIFF REQUIRED ADDITIONAL SURGERY FOR THE MESH PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S SPARE SLING SYSTEM| SPARE SLING SYSTEM