BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HONEYWELL

    MDR report key: 14647173 · Received June 9, 2022

    Report

    Report Number
    1314800-2022-00014
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    April 29, 2022
    Report Date
    December 1, 2022
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    KFZ
    UDI-DI
    70092926007057
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT HER DAUGHTER RECEIVED SEVERE BURNS ON HER ARM, HAND, AND WRIST ARE FROM HOT STEAM COMING FROM A WARM MIST HUMIDIFIER DURING USE. MEDICAL INTERVENTION WAS SOUGHT FOR HER INJURIES, AS WELL AS FOLLOW-UP CARE VISITS WITH BURN SPECIALISTS. THE PRODUCT DISPLAYS A CLEAR WARNING ON THE CORD THAT STATES, "WARNING KEEP OUT OF REACH OF CHILDREN HOT STEAM CAN CAUSE SERIOUS BURN INJURY" AND THE INSTRUCTIONS FOR PROPER USE ALSO HAVE CLEAR WARNINGS THAT STATE "WARNING: KEEP OUT OF REACH OF CHILDREN AND PETS. THIS PRODUCT PRODUCES HOT STEAM AND SHOULD BE PLACED IN AN AREA NOT ACCESSIBLE TO CHILDREN OR PETS. ENSURE THE POWER CORD IS ALSO SECURELY OUT OF REACH". KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT HER DAUGHTER RECEIVED SEVERE BURNS ON HER ARM, HAND, AND WRIST ARE FROM HOT STEAM COMING FROM A WARM MIST HUMIDIFIER DURING USE. MEDICAL INTERVENTION WAS SOUGHT FOR HER INJURIES, AS WELL AS FOLLOW-UP CARE VISITS WITH BURN SPECIALISTS. THE PRODUCT DISPLAYS A CLEAR WARNING ON THE CORD THAT STATES, "WARNING KEEP OUT OF REACH OF CHILDREN HOT STEAM CAN CAUSE SERIOUS BURN INJURY" AND THE INSTRUCTIONS FOR PROPER USE ALSO HAVE CLEAR WARNINGS THAT STATE "WARNING: KEEP OUT OF REACH OF CHILDREN AND PETS. THIS PRODUCT PRODUCES HOT STEAM AND SHOULD BE PLACED IN AN AREA NOT ACCESSIBLE TO CHILDREN OR PETS. ENSURE THE POWER CORD IS ALSO SECURELY OUT OF REACH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057209 HONEYWELL WARM MIST HUMIDIFIER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY HWM705B 22917KUO 70092926007057

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female Hospitalization| R| O