BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIONICARE KNEE DEVICE

    MDR report key: 899874 · Received August 14, 2007

    Report

    Report Number
    MW5003452
    Event Type
    Injury
    Date Received
    August 14, 2007
    Date of Event
    June 23, 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 A FEW HOURS, THE PT DEVELOPED BLISTERS ON HIS RIGHT KNEE AND THIGH. THE PT'S DR ADVISED HIM TO TREAT WITH OVER THE COUNTER BENADRYL.

    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 EPIDURAL STEROID INJECTION