BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIONICARE KNEE DEVICE

    MDR report key: 935943 · Received October 30, 2007

    Report

    Report Number
    MW5004222
    Event Type
    Injury
    Date Received
    October 30, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 29, 2007
    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 ON HER LEFT LEG AND SUFFERED BURNS TO HER LEG. THE PATIENT CONTACTED HER DR WHO ADVISED HER TO IMMEDIATELY DISCONTINUE USE.

    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