BEUDAMED
    FDA Adverse Event Other Summary report: N

    VICK

    MDR report key: 2930992 · Received January 16, 2013

    Report

    Report Number
    1314800-2013-00001
    Event Type
    Other
    Date Received
    January 16, 2013
    Date of Event
    January 2, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THAT THE USE OF HER HUMIDIFIER CAUSED BRONCHITIS. WHILE USING THE UNIT SHE SAYS IT MADE HER CHEST TIGHTEN UP AND SHE WENT TO THE EMERGENCY ROOM FOR TREATMENT. IF USED IN ACCORDANCE WITH THE INSTRUCTIONS, THIS HUMIDIFIER IS INTENDED TO INCREASE THE HUMIDITY IN THE ROOM. HER DOCTORS INFORMED HER TO START USING A WARM MIST HUMIDIFIER INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25096 VICK HUMIDIFIER KFZ KAZ INC V4500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other