BEUDAMED
    FDA Adverse Event Other Summary report: N

    KAZ

    MDR report key: 2009084 · Received February 17, 2011

    Report

    Report Number
    1314800-2011-00007
    Event Type
    Other
    Date Received
    February 17, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 16, 2011
    Manufacturer
    KAZ, INC.
    Product Code
    KFZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED HER SON PULLED THE UNIT DOWN ON HIMSELF CAUSING THE HOT WATER TO SPILL OUT AND BURN HIS FACE. THE INCIDENT WAS REPORTED TO KAZ FROM CAREMARK. THE INSTRUCTIONS FOR USE STATE TO KEEP THE UNIT AND CORD OUT OF THE REACH OF CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAZ VAPORIZER KFZ KAZ, INC. 2100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other