BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE

    MDR report key: 2181301 · Received July 21, 2011

    Report

    Report Number
    2183959-2011-00274
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    ON OR ABOUT (B)(6) 2006, AN APOGEE GRAFT WAS IMPLANTED TO TREAT PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT, "AFTER, AND AS A RESULT OF THE IMPLANTATION," THE PATIENT EXPERIENCED EXTREME PAIN, ADHESIONS, DYSPAREUNIA ENDOTHERMY INJURIES" THAT ARE ONGOING.

    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