BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN

    MDR report key: 12032322 · Received June 17, 2021

    Report

    Report Number
    MW5101981
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 16, 2021
    Manufacturer
    SOCLEAN INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LUNG IRRITATION, COUGH; PURCHASED A "SO CLEAN" CPAP SANITIZING DEVICE IN 2020 AND HAVE BEEN USING IT 2-3 TIMES PER WEEK (NOT DAILY) AS I HAD READ REPORTS THAT OZONE CAN DAMAGE CPAP INTERNAL COMPONENTS (E.G., RUBBER GASKETS, ETC.). SEVERAL MONTHS AFTER FIRST USE, I NOTICED A BLACK RESIDUE APPEARED IN MY WATER RESERVOIR, DIRECTLY UNDER THE BLACK RUBBER HOSE FROM THE SO CLEAN DEVICE. OVER THE PAST SEVERAL MONTHS, THE BLACK RESIDUE HAS CONTINUED TO ACCUMULATE IN THE RESERVOIR AND I HAVE BEEN REMOVING IT THE BEST I CAN. IT HAS SETTLED INTO THE FINE SEAMS ALONG THE RESERVOIR'S SIDES. I AM CLEANING THE DEVICE COMPONENTS USING SOAP AND WATER BUT STILL USING THE SO CLEAN EVERY 2-3 DAYS. IN THE PAST COUPLE OF WEEKS, I HAVE NOTICED A DISTINCT PAIN IN MY LUNGS AND COUGHING AT NIGHT AFTER I START USING MY CPAP, REQUIRING ME TO REMOVE THE MASK AND CATCH MY BREATH. I BELIEVE THE SO CLEAN'S OZONE MAY BE CAUSING DAMAGE TO ITS BLACK COLORED RUBBER HOSE COMPONENTS TO THE POINT THAT THE HOSE MATERIAL IS ENDING UP IN THE RESERVOIR AND BEING INHALED BY ME. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911201 SOCLEAN DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN INC. SC1200

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other