BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 8417224 · Received March 13, 2019

    Report

    Report Number
    1314800-2019-00016
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    January 25, 2019
    Report Date
    March 13, 2019
    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, US
    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 BURNS FROM THE HOT WATER THAT WAS SPILLED OUT OF THEIR WARM MIST HUMIDIFIER. IT WAS STATED THAT THE CHILD PULLED ON THE PRODUCT'S ELECTRICAL CORD WHICH PULLED THE UNIT OFF OF THEIR NIGHT STAND PULLED IT DOWN ON HIMSELF, AND THAT IS WHEN THE INJURIES OCCURRED. THE CHILD RECEIVED MEDICAL TREATMENT AT A HOSPITAL FOR A SECOND DEGREE BURNS ON HIS BACK, SHOULDER, CHEST, AND FACE, 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 OUT OF REACH". 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
    209951 VICKS WARM MIST HUMIDIFIER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY VWM845 16218

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Other| R