BEUDAMED
    FDA Adverse Event Other Summary report: N

    JACE K100

    MDR report key: 34737 · Received June 26, 1996

    Report

    Report Number
    2246559-1996-00006
    Event Type
    Other
    Date Received
    June 26, 1996
    Date of Event
    May 28, 1996
    Report Date
    June 4, 1996
    Manufacturer
    JACE SYSTEMS, INC.
    Product Code
    BXB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT AND WIFE ALLEGES RECEIVING RASH FROM USING CO'S DEVICE. PT AND WIFE WERE SEEN BY PHYSICIAN AND GIVEN OINTMENT FOR RASH. ADVISED TO STOP USING UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACE K100 SOFTGOODS FOR KNEE UNIT BXB JACE SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other