BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 15994932 · Received December 16, 2022

    Report

    Report Number
    1314800-2022-00024
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 21, 2022
    Report Date
    December 14, 2022
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    KFZ
    UDI-DI
    10328785001362
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT THE CONSUMER STATED THAT THEY NO LONGER HAVE THE DEVICE.

    Description of Event or Problem · 0

    A CONSUMER CALLED AND STATED THAT THEIR INFANT PULLED ON THE HUMIDIFIER'S CORD DURING OPERATION, WHICH CAUSED THE UNIT TO SPILL HOT WATER ONTO THE CHILD. THE CHILD RECEIVED MEDICAL TREATMENT AT AN EMERGENCY ROOM FOR SECOND DEGREE BURNS ON HIS NECK, EAR, AND CHEST, AND HE ALSO REQUIRED FOLLOW UP CARE FOR THESE 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 OUT OF REACH.", AS WELL AS " THE HUMIDIFIER SHOULD ALWAYS BE PLACED ON A FIRM, FLAT, WATERPROOF SURFACE AT LEAST FOUR FEET (1.2 M) AWAY FROM BEDSIDE, 12 INCHES (30 CM) FROM THE WALL AND OUT OF REACH OF CHILDREN AND PETS. BE SURE THE HUMIDIFIER IS IN A STABLE POSITION AND THE POWER CORD IS AWAY FROM HEATED SURFACES AND OUT OF THE WAY TO PREVENT THE HUMIDIFIER FROM BEING OVERTURNED." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT THE CONSUMER STATED THAT THEY NO LONGER HAVE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258294 VICKS WARM MIST HUMIDIFIER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY VWM845 UNKNOWN 10328785001362

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Male Required Intervention| O| H