BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDICHOICE WARM PACK

    MDR report key: 2223072 · Received August 21, 2011

    Report

    Report Number
    MW5021847
    Event Type
    Other
    Date Received
    August 21, 2011
    Date of Event
    April 8, 2011
    Report Date
    August 21, 2011
    Manufacturer
    COLDSTAR INTL INC
    Product Code
    IMD
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO REPLACE IV ACCESS ON AN INFANT, A HEATING PACK WAS PLACED DIRECTLY ON THE INFANT'S LEFT ARM. WHEN THE PACK WAS REMOVED LESS THAN 3 MINUTES LATER, THE INFANT'S SKIN WAS BLISTERED IN MULTIPLE AREAS AND SUFFERED A SECOND-DEGREE BURN. THE PACK WARMS TO 120 DEGREES, RECOMMENDS WRAPPING IN A TOWEL OR PROVIDED CLOTH SLEEVE PRIOR TO APPLICATION, AND STATES "DO NOT USE ON INFANTS." NO CLOTH SLEEVE WAS PROVIDED, AND THE 120 DEGREE PACK WAS THE SAME COLOR (RED AND WHITE STRIPED) AS ANOTHER, SLIGHTLY SMALLER, PACK BY ANOTHER MFR WHICH HEATS TO 110 DEGREES, DOES NOT REQUIRE A SLEEVE OR TOWEL, AND HAS NO INFANT RESTRICTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICHOICE WARM PACK WARM PACK IMD COLDSTAR INTL INC 69901

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other CATALOG #11443-512| CARDINAL HEALTH "INSTANT HOT PACK":