BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIONICARE KNEE DEVICE

    MDR report key: 899871 · Received August 14, 2007

    Report

    Report Number
    MW5003451
    Event Type
    Injury
    Date Received
    August 14, 2007
    Date of Event
    April 10, 2007
    Report Date
    August 10, 2007
    Manufacturer
    BIONICARE MEDICAL TECHNOLOGIES, INC
    Product Code
    NYN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER USING THE DEVICE FOR SEVERAL MONTHS, THE PT DEVELOPED A LARGE RASH ON HIS RIGHT THIGH. THE PT'S DR PRESCRIBED PREDNISONE FOR THE RASH, AND THE PT DISCONTINUED USE OF THE DEVICE. THE PT CALLED IN TO MEDICAL WHEN THE RASH HEALED AND WAS SENT ALOE VERA GEL TO USE WITH THE DEVICE.

    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 LIPITOR| GLUCOPHAGE