BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE

    MDR report key: 2142358 · Received June 20, 2011

    Report

    Report Number
    2183959-2011-00207
    Event Type
    Injury
    Date Received
    June 20, 2011
    Report Date
    June 1, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOMES AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT # 2183959-2011-00206. ON (B)(6) 2006, AN APOGEE DEVICE WAS IMPLANTED TO TREAT "PELVIC ORGAN PROLAPSE" AND IS NOW REPORTED TO HAVE CAUSED "EXTREME PAIN, EROSION OF HER INTERNAL BODILY TISSUE, DYSPAREUNIA, AND PERMANENT INJURY."

    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 PERIGEE MESH| LYNX SUPRAPUBIC SLING SYS