BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALGREENS

    MDR report key: 9978887 · Received April 20, 2020

    Report

    Report Number
    1314800-2020-00020
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    November 9, 2019
    Report Date
    June 10, 2020
    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
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A CONSUMER CALLED AND STATED THAT THEIR INFANT CHILD GRABBED THE VAPORIZER WHILE IT WAS IN OPERATION. THE CHILD RECEIVED MEDICAL TREATMENT AT A HOSPITAL FOR A THIRD DEGREE BURNS ON HER FINGERS, AND SHE ALSO REQUIRED FOLLOW UP CARE FOR THESE INJURIES. THE INSTRUCTIONS FOR PROPER USE HAVE VERY CLEAR WARNINGS THAT STATE, "WARNING: KEEP OUT OF THE REACH OF CHILDREN, ESPECIALLY CRAWLING INFANTS AND TODDLERS STEAM CAN CAUSE BURNS", AND "WARNING: KEEP OUT OF REACH OF CHILDREN. WE RECOGNIZE THAT MANY OF OUR CUSTOMERS USE VAPORIZERS IN HOMES WITH YOUNG CHILDREN. CAREFULLY SUPERVISE YOUR CHILDREN WHEN THE VAPORIZER IS OPERATING, ESPECIALLY CRAWLING INFANTS AND TODDLERS. FOR CHILDREN WHO CAN UNDERSTAND, PLEASE BE SURE TO TAKE THE TIME TO INSTRUCT THEM THAT THE VAPORIZER IS NOT A TOY. IT IS A DEVICE THAT PRODUCES HOT STEAM AND COULD CAUSE SEVERE BURNS AND INJURIES IF THEY DO NOT STAY AWAY FROM IT."

    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 CALLED AND STATED THAT THEIR INFANT CHILD GRABBED THE VAPORIZER WHILE IT WAS IN OPERATION. THE CHILD RECEIVED MEDICAL TREATMENT AT A HOSPITAL FOR A THIRD DEGREE BURNS ON HER FINGERS, AND SHE ALSO REQUIRED FOLLOW UP CARE FOR THESE INJURIES. THE INSTRUCTIONS FOR PROPER USE HAVE VERY CLEAR WARNINGS THAT STATE, "WARNING: KEEP OUT OF THE REACH OF CHILDREN, ESPECIALLY CRAWLING INFANTS AND TODDLERS STEAM CAN CAUSE BURNS", AND "WARNING: KEEP OUT OF REACH OF CHILDREN. WE RECOGNIZE THAT MANY OF OUR CUSTOMERS USE VAPORIZERS IN HOMES WITH YOUNG CHILDREN. CAREFULLY SUPERVISE YOUR CHILDREN WHEN THE VAPORIZER IS OPERATING, ESPECIALLY CRAWLING INFANTS AND TODDLERS. FOR CHILDREN WHO CAN UNDERSTAND, PLEASE BE SURE TO TAKE THE TIME TO INSTRUCT THEM THAT THE VAPORIZER IS NOT A TOY... IT IS A DEVICE THAT PRODUCES HOT STEAM AND COULD CAUSE SEVERE BURNS AND INJURIES IF THEY DO NOT STAY AWAY FROM IT." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441601 WALGREENS WARM STEAM VAPORIZER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY 2100-WGN 26719KTC

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Hospitalization| O| R