BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEP8 CPAP COMPANION SYSTEM

    MDR report key: 12173124 · Received July 14, 2021

    Report

    Report Number
    MW5102543
    Event Type
    Injury
    Date Received
    July 14, 2021
    Date of Event
    July 12, 2021
    Report Date
    July 12, 2021
    Manufacturer
    SLEEP 8, INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REACTION TO OZONE EXPOSURE; USING SLEEP8 OZONE CPAP CLEANER AND BEGAN HAVING FACIAL SKIN REACTION. I THOUGHT I HAD DEVELOPED A SILICONE ALLERGY. IT WOULD TAKE 3-5 DAYS FOR THE SKIN REACTION (DISTINCT SWELLING, REDNESS AND ITCHING) TO RESOLVE. AS SOON AS I USED MY CPAP AGAIN THE SKIN REACTION WOULD RETURN. I GOT A COMPLETELY NEW CPAP SETUP INCLUDING MACHINE AND MASK AND FOR THREE WEEKS WAS ABLE TO USE THE CPAP EVERY NIGHT WITHOUT ANY SKIN IRRITATION. ON (B)(6) 2021 I PUT THE HOSE AND MASK INTO THE SLEEP8 OZONE CPAP CLEANER AND RAN THE CLEANING CYCLE. JUST PRIOR TO GOING TO SLEEP, I REMOVED THE HOSE AND MASK FROM THE SLEEP8 CLEANING BAG, AND BEGAN MY CPAP THERAPY FOR THE NIGHT. I WOKE WITH SWELLING, REDNESS AND ITCHING IN DISTINCT RED SPLOTCHES WHERE MY MASK TOUCHED FACE (SPECIFICALLY UNDER LOWER LIP AND CHEEKS). MORE RESEARCH ONLINE BROUGHT ME TO A SIMILAR REPORT: HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFMAUDE/DETAIL.CFM?MDRFOI__ID=10689847&PC=LRJ. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066201 SLEEP8 CPAP COMPANION SYSTEM DISINFECTANT, MEDICAL DEVICES LRJ SLEEP 8, INC. SLP82043

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR