BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 6134555 · Received November 30, 2016

    Report

    Report Number
    1314800-2016-00061
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    October 19, 2016
    Report Date
    November 30, 2016
    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
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT THE UNIT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER CALLED AND STATED THAT THEIR INFANT RECEIVED 1ST AND SECOND DEGREE BURNS ON HIS HAND FROM THE HOT STEAM THAT WAS COMING OUT OF THEIR VAPORIZER. THE CHILD RECEIVED TREATMENT AT AN URGENT CARE CLINIC AND ALSO WAS ATTENDING WEEKLY VISITS AT A BURN CLINIC. THE CONSUMER ACKNOWLEDGED KNOWING THAT THE UNIT SHOULD NOT HAVE BEEN PLACED ON THE FLOOR, BUT HAD DONE SO ANYWAYS. THE INSTRUCTIONS FOR PROPER USE HAVE VERY CLEAR WARNINGS THAT STATE, "WARNING: KEEP OUT OF REACH OF CHILDREN. WE RECOGNIZE THAT MANY OF OUR CUSTOMERS USE VAPORIZERS IN HOMES WITH YOUNG CHILDREN. CAREFULLY SUPERVISE YOUR CHILDREN WHEN THE VAPORIZER IS OPERATING, ESPECIALLY CRAWLING INFANTS AND TODDLERS. FOR CHILDREN WHO CAN UNDERSTAND, PLEASE BE SURE TO TAKE THE TIME TO INSTRUCT THEM THAT THE VAPORIZER IS NOT A TOY... IT IS A DEVICE THAT PRODUCES HOT STEAM AND COULD CAUSE SEVERE BURNS AND INJURIES IF THEY DO NOT STAY AWAY FROM IT." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786159 VICKS VAPORIZER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY V150SGN 17416

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Hospitalization| O| R