BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICKS

    MDR report key: 8484218 · Received April 4, 2019

    Report

    Report Number
    1314800-2019-00020
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 2, 2019
    Report Date
    April 4, 2019
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    KFZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A CONSUMER CALLED AND STATED SHE RECEIVED FIRST AND SECOND DEGREE BURNS ON HER FOOT FROM THE HOT STEAM THAT WAS COMING OUT OF THEIR VAPORIZER. THE WOMAN RECEIVED MEDICAL TREATMENT AT AN URGENT CARE FACILITY, AND FOLLOW UP CARE WAS REQUIRED DUE TO AN INFECTION. THE INSTRUCTIONS FOR PROPER USE HAVE VERY CLEAR WARNINGS THAT STATE, "IT IS A DEVICE THAT PRODUCES HOT STEAM AND COULD CAUSE SEVERE BURNS AND INJURIES IF THEY DO NOT STAY AWAY FROM IT", AND "VAPORIZER SHOULD ALWAYS BE PLACED ON A FIRM, FLAT, WATERPROOF SURFACE AT LEAST FOUR FEET AWAY FROM BEDSIDE AND OUT OF REACH OF PATIENT AND CHILDREN." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275451 VICKS WARM STEAM VAPORIZER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY V150SG 27018KTC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R