BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HONEYWELL

    MDR report key: 8133375 · Received December 5, 2018

    Report

    Report Number
    1314800-2018-00036
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    October 21, 2018
    Report Date
    December 4, 2018
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    KFZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING, BUT THE ITEM HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER CALLED AND STATED THAT THEIR INFANT CHILD RECEIVED BURNS FROM THE HOT STEAM THAT WAS COMING OUT OF THEIR WARM MIST HUMIDIFIER. THE CHILD RECEIVED MEDICAL TREATMENT AT A HOSPITAL FOR A SECOND DEGREE BURN ON HIS HAND, AND HE ALSO REQUIRED FOLLOW UP CARE FOR HIS INJURIES. THE INSTRUCTIONS FOR PROPER USE HAVE VERY CLEAR WARNINGS THAT STATE, "WARNING: KEEP OUT OF REACH OF CHILDREN. THIS PRODUCT PRODUCES HOT STEAM AND SHOULD BE PLACED IN AN AREA NOT ACCESSIBLE TO CHILDREN OR PETS WITH THE POWER CORD ALSO SECURELY OUT OF REACH" AND "CAUTION: HOT STEAM MAY CAUSE BURNS". KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973350 HONEYWELL WARM MIST HUMIDIFIER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY HWM-340BC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R