BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE

    MDR report key: 2852350 · Received November 27, 2012

    Report

    Report Number
    2183959-2012-03024
    Event Type
    Injury
    Date Received
    November 27, 2012
    Report Date
    October 23, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    RELATED TO MFR REPORT BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH AN APOGEE ON EITHER (B)(6) 2007 OR (B)(6) 2010. IT WAS ALLEGED THE PLAINTIFF SUFFERED/WILL CONTINUE TO SUFFER PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND INABILITY TO ENGAGE IN CHOSEN AND NECESSARY ACTIVITIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability GYNECARE TVT| MONARC SLING SYSTEM| GYNECARE TVT| MONARC SLING SYSTEM