BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE

    MDR report key: 1252414 · Received December 3, 2008

    Report

    Report Number
    2183959-2008-00028
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 16, 2006
    Report Date
    December 3, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WHO WAS IMPLANTED WITH APOGEE GRAFT IN 2006, HAD A SECOND PROCEDURE DONE FIVE MONTHS LATER, TO RELEASE AN ADHESION BAND AND PARTIALLY EXCISE THE ARMS OF THE APOGE DUE TO CLAIMED PAIN. A FURTHER PROCEDURE TO REMOVE THE REMAINDER OF THE GRAFT WAS PERFORMED THE FOLLOWING YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APOGEE GRAFT FTL AMERICAN MEDICAL SYSTEMS, INC. 72404089 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R