BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH

    MDR report key: 9831407 · Received March 13, 2020

    Report

    Report Number
    1314800-2020-00014
    Event Type
    Injury
    Date Received
    March 13, 2020
    Report Date
    March 13, 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

    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 SHE RECEIVED SECOND DEGREE BURNS ON HER THIGH FROM HOT WATER THAT SPILLED OUT OF THE PERSONAL STEAM INHALER. IT IS UNKNOWN WHETHER MEDICAL INTERVENTION WAS SOUGHT FOR THEIR INJURIES. INCIDENTS OF THIS NATURE ARE MOST LIKELY TO OCCUR IF THE UNIT IS BEING MOVED OR LIFTED DURING USE. 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
    294965 CVS HEALTH STEAM INHALER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY GIH120 23519MGH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other