BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIONICARE KNEE DEVICE

    MDR report key: 899870 · Received August 14, 2007

    Report

    Report Number
    MW5003450
    Event Type
    Other
    Date Received
    August 14, 2007
    Date of Event
    May 29, 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

    THE PT USED THE DEVICE ON HER RIGHT LEG FOR A COUPLE OF HOURS AND EXPERIENCED SWELLING ABOVE THE RIGHT ANKLE. DUE TO THE PT'S DEFIBRILLATOR, SHE CONTACTED HER HEART DR WHO ADVISED HER TO DISCONTINUE USE.

    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 COREG| CELEBREX| BACTRIM| COUMADIN| NORVASC| NORTRIPTYLINE| LASIX| ATACAND HCT| NEXIUM