BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 6157748 · Received December 9, 2016

    Report

    Report Number
    1314800-2016-00066
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    October 30, 2016
    Report Date
    December 9, 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
    IL, 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 PRODUCT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT THE UNIT LEAKED, AND THIS RESULTED IN BURNS TO HER 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 WITH ANTIBIOTICS AND BURN CREAM. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810796 VICKS STEAM INHALER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY V1200 23215

    Patients

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