BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 24176853 · Received January 26, 2026

    Report

    Report Number
    24176853
    Event Type
    Injury
    Date Received
    January 26, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 7, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KYR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NURSE MADE "HOT PACK" USING BAG LABELED "ICE BAG" WITH WASH CLOTH INSIDE AND JUST ENOUGH WARM/HOT WATER TO WET THE WASH CLOTH INSIDE THE PACK. HOT PACK PLACED DIRECTLY ON PT SKIN. PT LEG WAS NUMB DUE TO HAVING AN EPIDURAL BLOCK SO PT WAS NOT ABLE TO FEEL HOT TEMPERATURE. SUFFERED SECOND DEGREE BURNS BLISTERING LEG. WATER AND PACK TEMPERATURE WAS PALPATED BY RN BEFORE AND IMMEDIATELY FOLLOWING THE INCIDENT. PARTS OF THE PACK WERE FOUND TO BE ABNORMALLY HOT FOLLOWING THE INCIDENT, AND SOME WATER HAD LEAKED OUT. CAUSE OF PACK BEING HOT ENOUGH TO BURN THE PATIENT IS UNKNOWN SINCE BOILING WATER WAS NOT USED AND RN PALPATED COMFORTABLE TEMPERATURE PRIOR TO ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240079 CARDINAL HEALTH BAG, ICE KYR CARDINAL HEALTH 200, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 29 DA Female