BEUDAMED
    FDA Adverse Event Other Summary report: N

    8031673-2009-00001

    MDR report key: 1341391 · Received February 24, 2009

    Report

    Report Number
    8031673-2009-00001
    Event Type
    Other
    Date Received
    February 24, 2009
    Product Code
    JJE
    PMA / PMN Number
    K901674
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    TOSOH BIOSCIENCE, INC. BECAME AWARE OF INFO THAT REASONABLY SUGGESTS THAT ONE OF FOUR MARKETED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, SERIOUS INJURY, OR COULD HAVE MALFUNCTIONED AND MAY BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THIS MALFUNCTION WERE TO RECUR. THE INSTRUMENT IN QUESTION WAS PURCHASED FROM AN UNAUTHORIZED THIRD PARTY AND TO OUR KNOWLEDGE IS NOT CERTIFIED TO MEET TOSOH BIOSCIENCE, INC. PERFORMANCE SPEC, INCLUDING ALL CLAIMS MADE IN OUR LABELING FOR THE DEVICE. FURTHERMORE, TOSOH BIOSCIENCE, INC. CANNOT GUARANTEE THE INSTRUMENT WILL PERFORM AS INTENDED. IT WAS NOTED BY TOSOH BIOSCIENCE, INC. SYSTEM SALES SPECIALISTS THAT THE SERIAL NUMBER ON THE INSTRUMENT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JJE

    Patients

    Seq Age Sex Outcome Treatment
    1