BEUDAMED
    FDA Adverse Event Other Summary report: N

    VICKS

    MDR report key: 2860336 · Received November 26, 2012

    Report

    Report Number
    1314800-2012-00046
    Event Type
    Other
    Date Received
    November 26, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 5, 2012
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER STATED THE VAPORIZER CAUSED BURNS TO HER DAUGHTERS HEAD AS A RESULT OF THE UNIT OVER-BOILING. CONSUMERS ARE INSTRUCTED IN THE OWNERS MANUAL TO KEEP THE UNIT AWAY FROM CHILDREN WHILE IN USE AND HOW TO PREVENT THE WATER FROM OVER-BOILING. THE CHILD WAS TAKEN TO THE EMERGENCY ROOM BUT NO FURTHER MEDICAL ATTENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICKS HUMIDIFER IRT KAZ INC V150SG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other