BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 6063448 · Received October 28, 2016

    Report

    Report Number
    1314800-2016-00056
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 30, 2016
    Report Date
    November 21, 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
    MO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING, BUT THE CONSUMER IS REFUSING TO DO SO.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT THE UNIT LEAKED, AND THIS RESULTED IN BURNS TO HIS SON FROM THE HOT WATER THAT SPILLED OUT OF THE PERSONAL STEAM INHALER. MEDICAL INTERVENTION WAS SOUGHT FOR THEIR INJURIES, AND IT WAS STATED THAT THEY THE CHILD WAS TREATED AT A WOUND CENTER. THE INSTRUCTIONS FOR PROPER USE HAVE A CLEAR WARNING THAT THE PRODUCT SHOULD ONLY BE USED ON A FLAT LEVEL SURFACE TO AVOID SPILLING WATER, AND ALSO TO KEEP OUT OF REACH OF CHILDREN. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT THE CONSUMER HAS REFUSED TO DO SO.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT THE UNIT LEAKED, AND THIS RESULTED IN BURNS TO HIS SON FROM THE HOT WATER THAT SPILLED OUT OF THE PERSONAL STEAM INHALER. MEDICAL INTERVENTION WAS SOUGHT FOR THEIR INJURIES, AND IT WAS STATED THAT THEY THE CHILD WAS TREATED AT A WOUND CENTER. THE INSTRUCTIONS FOR PROPER USE HAVE A CLEAR WARNING THAT THE PRODUCT SHOULD ONLY BE USED ON A FLAT LEVEL SURFACE TO AVOID SPILLING WATER, AND ALSO TO KEEP OUT OF REACH OF CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716454 VICKS STEAM INHALER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY V1200 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| O