BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 6646232 · Received June 16, 2017

    Report

    Report Number
    1314800-2017-00030
    Event Type
    Injury
    Date Received
    June 16, 2017
    Date of Event
    May 15, 2017
    Report Date
    July 7, 2017
    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
    PR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE RECEIVED SECOND DEGREE BURNS ON HER SHOULDER FROM HOT WATER THAT SPILLED OUT OF THE PERSONAL STEAM INHALER. MEDICAL INTERVENTION WAS SOUGHT FOR THEIR INJURIES. THE CONSUMER STATED THAT SHE WAS MOVING 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", AND "CAUTION: DO NOT PLACE ON LAP OR LIFT IN YOUR HANDS WHILE IN OPERATION AND IF THE UNIT STILL CONTAINS WATER." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE RECEIVED SECOND DEGREE BURNS ON HER SHOULDER FROM HOT WATER THAT SPILLED OUT OF THE PERSONAL STEAM INHALER. MEDICAL INTERVENTION WAS SOUGHT FOR THEIR INJURIES. THE CONSUMER STATED THAT SHE WAS MOVING 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", AND "CAUTION: DO NOT PLACE ON LAP OR LIFT IN YOUR HANDS WHILE IN OPERATION AND IF THE UNIT STILL CONTAINS WATER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427391 VICKS STEAM INHALER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY V1200 15816

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R