BEUDAMED
    FDA Adverse Event Other Summary report: N

    VICKS

    MDR report key: 2930969 · Received January 16, 2013

    Report

    Report Number
    1314800-2013-00003
    Event Type
    Other
    Date Received
    January 16, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 11, 2013
    Manufacturer
    KAZ INC
    Product Code
    KFZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE PERSONAL STEAM INHALER LEAKED WATER WHICH CAUSED BURNS TO HIS CHEST. THE INSTRUCTIONS FOR USE STATE TO ONLY USE THE UNIT ON A FLAT LEVEL SURFACE. A BURN OF THIS NATURE CAN BE CAUSED DUE TO PLACING THE UNIT ON A SURFACE THAT IS NOT FLAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24200 VICKS HUMIDIFIER KFZ KAZ INC V1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other