BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEP8 OZONE CPAP CLEANER

    MDR report key: 10689847 · Received October 15, 2020

    Report

    Report Number
    MW5097262
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    September 20, 2020
    Report Date
    October 13, 2020
    Manufacturer
    SLEEP 8, INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REACTION TO OZONE EXPOSURE; USING THE SLEEP8 OZONE CPAP CLEANER FOR 2-3 WEEKS AND EXPERIENCED CHEST DISCOMFORT AND A SEVERE FACIAL SKIN REACTION. FIRST THOUGHT CHEST DISCOMFORT WAS DUE TO INCREASED PRESSURES AND SKIN REACTION WAS DUE TO A SILICONE ALLERGY. AFTER RULING OUT THE SILICONE ALLERGY USING A MASK LINER AND STILL HAVING THE SKIN REACTION THE ONLY REMAINING PIECE OF THE PUZZLE WAS THE OZONE CLEANING SYSTEM. STOPPED USING IT AND THE REACTION DID NOT REOCCUR AND MY MORNING CHEST DISCOMFORT HAS SUBSIDED. IT APPEARS THE OZONE GAS WAS LINGERING IN MY CPAP HOSE AND REMAINING ON MY MASK, LINER AND HEADGEAR IN A QUANTITY THAT WAS CONCENTRATED ENOUGH TO CREATE THE SKIN REACTION. ON OCCASION I WAS LEAVING MY CPAP HOSE, MASK, LINER, AND HEADGEAR IN THE SLEEP8 BAG UP UNTIL JUST BEFORE USE SO I'M SURE THAT HAD A LOT TO DO WITH THE LEVEL OF OZONE I WAS EXPOSED TO. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146485 SLEEP8 OZONE CPAP CLEANER DISINFECTANT, MEDICAL DEVICES LRJ SLEEP 8, INC. SLEEP82043

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R