BEUDAMED
    FDA Adverse Event Other Summary report: N

    VICKS

    MDR report key: 3777517 · Received April 17, 2014

    Report

    Report Number
    1314800-2014-00029
    Event Type
    Other
    Date Received
    April 17, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 31, 2014
    Manufacturer
    KAZ USA, 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

    A CONSUMER REPORTED THAT THEY ALLEGEDLY HAD RECEIVED A BURN FROM ONE OF OUR VAPORIZERS. THE CONSUMER ALLEGES THAT THE PRODUCT SHOT WATER OUT OF IT, WHICH CAUSED A SECOND DEGREE BURN ON HER FOOT. SHE WAS TREATED AT A HOSPITAL, AND IS DOING FINE NOW. KAZ HAS REQUESTED THAT THE UNIT BE RETURNED TO OUR COMPANY FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236387 VICKS HUMIDIFIER KFZ KAZ USA, INC. V150SG N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other