BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAZ VICKS

    MDR report key: 6266403 · Received January 18, 2017

    Report

    Report Number
    MW5067339
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    January 2, 2017
    Report Date
    January 6, 2017
    Manufacturer
    KAZ VICKS
    Product Code
    KFZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER USING THIS VAPORIZER, THE WATER IN THE TANK TURNS BLACK. THE WATER CONTAINS SMALL PIECES OF BLACK FLAKES. THE MIST SMELLS OF PLASTIC. THIS OCCURED AFTER DAY ONE OF USE AND WE THOUGHT IT WOULD STOP AFTER CONTINUAL USE. THIS HAS OCCURED AFTER EVERY TIME IT IS USED AND THIS HAS BEEN FOR APPROXIMATELY THREE YEARS. MFR DATE CODE: 26510KTC. (B)(6). THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT: NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43071 KAZ VICKS WARM STEAM VAPORIZER KFZ KAZ VICKS V150SG2UPC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR