BEUDAMED
    FDA Adverse Event Other Summary report: N

    VICKS

    MDR report key: 1790605 · Received August 2, 2010

    Report

    Report Number
    1314800-2010-00032
    Event Type
    Other
    Date Received
    August 2, 2010
    Date of Event
    October 12, 2009
    Report Date
    July 29, 2010
    Manufacturer
    KAZ, INC.
    Product Code
    KFZ
    PMA / PMN Number
    950116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RECEIVED NOTIFICATION THAT THE CONSUMER WAS BURNED ON HER LEGS BY THE PERSONAL STEAM INHALER. THE CONSUMER SOUGHT MEDICAL ATTENTION FOR HER BURNS AND THE MEDICAL REPORTS STATE PARTIAL THICKNESS BURNS WITH NO OTHER COMPLICATIONS. THIS DEVICE IS INTENDED TO BE USED ON A FLAT LEVEL SURFACE SUCH A TABLE, TO RECEIVE BURNS IN THE MANNER THE CONSUMER WOULD HAVE TO HAVE BEEN CARRYING OR HOLDING THE UNIT WHILE IN USE WHICH IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICKS PERSONAL STEAM INHALER KFZ KAZ, INC. V1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other