BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH

    MDR report key: 8569763 · Received May 1, 2019

    Report

    Report Number
    1314800-2019-00025
    Event Type
    Injury
    Date Received
    May 1, 2019
    Report Date
    April 30, 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

    Additional Manufacturer Narrative · 1

    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 · 1

    A CONSUMER REPORTED THAT HER EMPLOYER RECEIVED SECOND DEGREE BURNS ON HER LEFT BREAST FROM HOT WATER THAT SPILLED OUT OF THE PERSONAL STEAM INHALER. MEDICAL INTERVENTION WAS SOUGHT FOR THEIR INJURIES TWO DAYS AFTER THE INCIDENT OCCURED. IT WAS STATED THAT SHE WAS CHANGING THE POSITIONING OF THE UNIT WHEN THE INJURY OCCURRED. THE INSTRUCTIONS FOR PROPER USE HAVE A CLEAR WARNING THAT STATES "THE APPLIANCE SHOULD ALWAYS BE PLACED ON A FIRM, FLAT WATERPROOF SURFACE", "CAUTION: DO NOT PLACE ON LAP OR LIFT IN YOUR HANDS WHILE IN OPERATION AND IF THE UNIT STILL CONTAINS WATER", AND "NEVER MOVE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED OR TIPPED OVER CAUSING INJURY OR BURNS". KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362077 CVS HEALTH STEAM INHALER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY GIH120 24418

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R