BEUDAMED
    FDA Adverse Event Summary report: N

    MIRACLE MIST BREATHE EASY

    MDR report key: 8491836 · Received April 5, 2019

    Report

    Report Number
    MW5085638
    Date Received
    April 5, 2019
    Date of Event
    December 26, 2018
    Report Date
    February 20, 2019
    Manufacturer
    ONTEL PRODUCTS CORPORATION
    Product Code
    KFZ
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT IS MIRACLE MIST BREATHE EASY ROOM HUMIDIFIER BOUGHT AT (B)(6) IN 2017. ITS MODEL IS 17002, ONTEL PRODUCTS CORP, (B)(4). MADE IN (B)(4). THE PRODUCT FUNCTIONS AS ADVERTISED. MY PROBLEM IS THAT IT IS NOT DESIGNED TO HAVE A WICK (A FILTER) AND EVEN THOUGH I WAS USING CITY WATER, THE HUMIDIFIER, I EVENTUALLY DISCOVERED, WAS SPEWING OUT A WHITE CONTAMINATE THAT WAS GOING THROUGH MY HOME'S DUCT WORK AND CLOGGING UP THE FURNACE FILTER, WHICH IN TURN STOPPED THE AIR FLOW CAUSING THE FURNACE TO STOP AND COOL DOWN TO ABOUT 62 DEGREES BEFORE COMING BACK ON. I SPENT ABOUT (B)(6) ON 3 SERVICE CALLS BEFORE I DISCOVERED IT WAS THE FILTER AND NOT THE FURNACE. WHAT IS DISTURBING IS THAT I WAS BREATHING IN THAT CONTAMINATE FROM THE AIR FOR SEVERAL WEEKS BEFORE I DISCOVERED WHAT WAS HAPPENING. I RECOMMEND THAT ALL VAPORIZERS AND HUMIDIFIERS HAVE WICKS/FILTERS SO THAT WATER CONTAMINATES ARE NOT UNSUSPECTINGLY BEING PUT OUT IN OUR HOMES IN THE AIR THAT WE BREATHE. COULD BE BAD FOR PEOPLE WITH ASTHMA. OR AT LEAST WARN PEOPLE THAT TAP WATER MAY BE HARMFUL TO THEIR HEALTH. I PURCHASED IN (B)(6) 2018. WHEN I MOVED TO DIFFERENT TOWN I NOTICED PROBLEM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282409 MIRACLE MIST BREATHE EASY HUMIDIFIER, NON-DIRECT PATIENT INTERFACE KFZ ONTEL PRODUCTS CORPORATION 17002

    Patients

    Seq Age Sex Outcome Treatment
    1