BEUDAMED
    FDA Adverse Event Other Summary report: N

    CODE ALERT

    MDR report key: 490843 · Received October 23, 2003

    Report

    Report Number
    490843
    Event Type
    Other
    Date Received
    October 23, 2003
    Date of Event
    June 1, 2003
    Report Date
    July 1, 2003
    Manufacturer
    RF TECHNOLOGIES, INC
    Product Code
    KMI
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SECURITY BAND TOO TIGHT. UPON ARRIVAL FOOT WARM AND PINK AN ASSESSMENT WAS COMPLETED AND PT'S RIGHT FOOT WAS FOUND MOTTLED AND COOL TO TOUCH. THE SECURITY BAND ON RIGHT LEG WAS REMOVED. POSITIVE PEDAL PULSES WERE PRESENT. FOOT COLOR AND TEMPERATURE RETURNED TO BASELINE. NO ADVERSE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODE ALERT SECURITY BAND KMI RF TECHNOLOGIES, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other