BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIONICARE KNEE DEVICE

    MDR report key: 980059 · Received January 11, 2008

    Report

    Report Number
    MW5004969
    Event Type
    Injury
    Date Received
    January 11, 2008
    Date of Event
    December 21, 2007
    Report Date
    January 10, 2008
    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

    THE PATIENT DEVELOPED A BURN ON THE KNEE/THIGH AREA AND EXPERIENCED PAIN FOR SEVERAL DAYS AFTER USING 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