BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 6141527 · Received December 2, 2016

    Report

    Report Number
    1314800-2016-00064
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    October 28, 2016
    Report Date
    December 2, 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
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE TIPPED THE UNIT WHILE MOVING IT, AND THIS RESULTED IN BURNS TO HER CHEST AND STOMACH FROM THE HOT WATER THAT SPILLED OUT OF THE PERSONAL STEAM INHALER. MEDICAL INTERVENTION WAS SOUGHT FOR THEIR INJURIES TWO DAYS AFTER THE INITIAL INCIDENT OCCURRED. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT THE PRODUCT SHOULD ONLY BE USED ON A FIRM, FLAT SURFACE, AND ALSO TO "NEVER MOVE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED OR TIPPED OVER CAUSING INJURY". 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
    791755 VICKS STEAM INHALER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY V1200 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R