BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 23244180 · Received October 8, 2025

    Report

    Report Number
    1314800-2025-00026
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 20, 2025
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    KFZ
    UDI-DI
    00328785012835
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 WHILE USING A VICKS STEAM INHALER (MODEL VIH200C), THE DEVICE ALLEGEDLY OPENED UNEXPECTEDLY DESPITE BEING PROPERLY LOCKED, CAUSING HOT WATER TO SPILL ONTO THEIR SISTER'S CHEST AND STOMACH AND ONTO THE CONSUMER'S RIGHT HAND. THE SISTER ALLEGEDLY SUSTAINED BURNS AND BLISTERING, WHILE THE CONSUMER REPORTED BURNS TO ALL FINGERS, WHICH BECAME BLACK AND SWOLLEN. BOTH INDIVIDUALS REPORTEDLY SOUGHT EMERGENCY MEDICAL TREATMENT AND RECEIVED BURN CARE, MEDICATION, AND FOLLOW-UP. THE INCIDENT ALLEGEDLY AGGRAVATED THE SISTER'S PRE-EXISTING BREATHING CONDITION AND CAUSED EMOTIONAL DISTRESS FOR BOTH PARTIES. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "CAUTION: NEVER MOVE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED, SHAKEN OR TIPPED OVER CAUSING INJURY OR BURNS", "DO NOT MOVE, LIFT, SHAKE, TILT OR DISASSEMBLE WHILE IN OPERATION OR IF IT STILL CONTAINS HOT WATER", AS WELL AS "ALLOW THE APPLIANCE TO COOL FOR AT LEAST 20 MINUTES BEFORE MOVING OR REFILLING IT".

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT WHILE USING A VICKS STEAM INHALER (MODEL VIH200C), THE DEVICE ALLEGEDLY OPENED UNEXPECTEDLY DESPITE BEING PROPERLY LOCKED, CAUSING HOT WATER TO SPILL ONTO THEIR SISTER'S CHEST AND STOMACH AND ONTO THE CONSUMER'S RIGHT HAND. THE SISTER ALLEGEDLY SUSTAINED BURNS AND BLISTERING, WHILE THE CONSUMER REPORTED BURNS TO ALL FINGERS, WHICH BECAME BLACK AND SWOLLEN. BOTH INDIVIDUALS REPORTEDLY SOUGHT EMERGENCY MEDICAL TREATMENT AND RECEIVED BURN CARE, MEDICATION, AND FOLLOW-UP. THE INCIDENT ALLEGEDLY AGGRAVATED THE SISTER'S PRE-EXISTING BREATHING CONDITION AND CAUSED EMOTIONAL DISTRESS FOR BOTH PARTIES. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "CAUTION: NEVER MOVE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED, SHAKEN OR TIPPED OVER CAUSING INJURY OR BURNS", "DO NOT MOVE, LIFT, SHAKE, TILT OR DISASSEMBLE WHILE IN OPERATION OR IF IT STILL CONTAINS HOT WATER", AS WELL AS "ALLOW THE APPLIANCE TO COOL FOR AT LEAST 20 MINUTES BEFORE MOVING OR REFILLING IT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565514 VICKS PERSONAL STEAM INHALER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY VIH200C 17824D 00328785012835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R