BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIONICARE KNEE DEVICE

    MDR report key: 947943 · Received November 13, 2007

    Report

    Report Number
    MW5004391
    Event Type
    Other
    Date Received
    November 13, 2007
    Date of Event
    October 4, 2007
    Report Date
    November 12, 2007
    Manufacturer
    BIONICARE MEDICAL TECHNOLOGIES, INC.
    Product Code
    NYN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED A RASH ON THE KNEE AFTER USING THE DEVICE FOR APPROXIMATELY THREE WEEKS. THE RASH CONTINUED TO SPREAD DOWN THE SIDE OF THE PT'S LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIONICARE KNEE DEVICE BIONICARE KNEE DEVICE NYN BIONICARE MEDICAL TECHNOLOGIES, INC. B1000

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other