BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIONICARE KNEE DEVICE

    MDR report key: 998055 · Received February 11, 2008

    Report

    Report Number
    MW5005423
    Event Type
    Injury
    Date Received
    February 11, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 11, 2008
    Manufacturer
    BIONICARE
    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 USED THE DEVICE FOR APPROXIMATELY THREE WEEKS USING EIGHT TO TEN HOURS A DAY. PATIENT DEVELOPED WATER IN HER RIGHT KNEE AND WAS SEEN BY DR TO DRAIN FLUID AND ADMINISTER CORTISONE SHOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIONICARE KNEE DEVICE BIONICARE KNEE DEVICE NYN BIONICARE B1000

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other