BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 8464255 · Received March 29, 2019

    Report

    Report Number
    1314800-2019-00019
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    September 3, 2018
    Report Date
    June 26, 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
    MO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT SHE RECEIVED 2ND DEGREE BURNS FROM BOILING WATER WHILE FILLING HER WARM STEAM VAPORIZER. SHE STATED THAT SHE WAS TREATED AT A HOSPITAL FOR HER INJURIES. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS WHICH STATES THAT, "IT IS A DEVICE THAT PRODUCES HOT STEAM AND COULD CAUSE SEVERE BURNS AND INJURIES", AND "DO NOT REMOVE THE APPLIANCE HEAD DURING OPERATION OR WITHIN 20-30 MINUTES AFTER IT IS UNPLUGGED."

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING, BUT THE ITEM HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE RECEIVED 2ND DEGREE BURNS FROM BOILING WATER WHILE FILLING HER WARM STEAM VAPORIZER. SHE STATED THAT SHE WAS TREATED AT A HOSPITAL FOR HER INJURIES. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS WHICH STATES THAT, "IT IS A DEVICE THAT PRODUCES HOT STEAM AND COULD CAUSE SEVERE BURNS AND INJURIES", AND "DO NOT REMOVE THE APPLIANCE HEAD DURING OPERATION OR WITHIN 20-30 MINUTES AFTER IT IS UNPLUGGED." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258466 VICKS WARM STEAM VAPORIZER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY V150SG 23317KTC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R