BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 3143154 · Received May 31, 2013

    Report

    Report Number
    1314800-2013-00024
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 24, 2013
    Manufacturer
    KAZ, INC.
    Product Code
    KFZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING 2ND DEGREE BURNS TO THE RIGHT SIDE OF HER LEG. SHE ALLEGES THE UNIT FELL OVER BY ITSELF CAUSING HOT WATER TO SPILL OUT OF THE UNIT. THE INSTRUCTIONS FOR PROPER USE STATE TO ONLY USE THE UNIT ON A FLAT, LEVEL SURFACE TO PREVENT WATER FROM SPILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242338 VICKS HUMIDIFIER KFZ KAZ, INC. V1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other