BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE

    MDR report key: 1910317 · Received November 23, 2010

    Report

    Report Number
    2183959-2010-00435
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    August 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINICAL PATIENT #(B)(6) WAS IMPLANTED WITH ELEVATE ON (B)(6) 2009. ON (B)(6) 2010, THE PT PRESENTED WITH "FIBROUS CAPSULE FORMATION-SHRINKAGE OF APICAL AREA LEADING TO DYSPAREUNIA." THE PHYSICIAN DETERMINED THE EVENT IS RELATED TO THE DEVICE. NO MEDICAL INTERVENTION. EVENT STATUS: CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATE SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. 72009301 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability