BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 4960965 · Received July 30, 2015

    Report

    Report Number
    1314800-2015-00059
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 30, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    KFZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS FORWARDED TO OUR COMPANY BY (B)(4), THE LICENSOR OF THE VICKS BRAND NAME TO KAZ USA, INC. THE CONSUMER REPORTED THAT THEIR DAUGHTER HAD TIPPED THE UNIT OVER, AND RECEIVED 2ND DEGREE BURNS ON HER LEFT THIGH FROM THE HOT WATER THAT SPILLED OUT OF THE PERSONAL STEAM INHALER. MEDICAL INTERVENTION WAS SOUGHT FOR HER INJURIES. THE INSTRUCTIONS FOR PROPER USE HAVE A CLEAR WARNING TO NEVER HOLD THE UNIT WHILE IN OPERATION AND THAT THE UNIT SHOULD NOT BE OPERATED BY CHILDREN. THE INSTRUCTIONS ALSO STATE THAT THE PRODUCT SHOULD ONLY BE USED ON A FLAT LEVEL SURFACE TO AVOID SPILLING WATER. 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
    495481 VICKS HUMIDIFIER KFZ KAZ USA, INC. V1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Disability