BEUDAMED
    FDA Adverse Event Other Summary report: N

    JACE 2010

    MDR report key: 44950 · Received October 23, 1996

    Report

    Report Number
    2247030-1996-00006
    Event Type
    Other
    Date Received
    October 23, 1996
    Date of Event
    October 4, 1996
    Report Date
    October 7, 1996
    Manufacturer
    JACE SYSTEMS
    Product Code
    BXB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINIC RESET/OUTPT WHILE RESETTING UNIT AT THE CLINIC. MACHINE WENT BEYOND EXTENSION PARAMETERS. PSR STOPPED DEVICE, TOOK PT OUT, AND ICE WAS APPLIED. PT COMPLAINED OF PAIN. PT CALLED DR WHO ADVISED STOP CPM USE FOR 1 WEEK. IF PAIN PERSISTS, DR WOULD LIKE TO SEE PT. AT THIS TIME, NO MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACE 2010 WRIST CPM BXB JACE SYSTEMS JACE2010-W550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other
    2