BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACK FROST

    MDR report key: 1980068 · Received January 31, 2011

    Report

    Report Number
    MW5019251
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 31, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A NURSING ASSISTANT ACTIVATED TWO HOT PACKS AND GAVE IT TO A PT TO HOLD IN HIS HANDS. LATER A NURSE FOUND THE PACKS IN THE BED NEXT TO THE PT'S FLANK AREA. SUBSEQUENTLY, IT WAS NOTICED THAT THE PT HAD BLISTERING ON THE LEFT FLANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACK FROST INSTANT HOT PACK IMD CARDINAL HEALTH NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other