BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN 2

    MDR report key: 10390619 · Received August 11, 2020

    Report

    Report Number
    MW5095997
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    August 10, 2020
    Report Date
    August 10, 2020
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    UDI-DI
    18729300086
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A SOCLEAN DEVICE TO CLEAN MY CPAP AT THE RECOMMENDATION OF MY CPAP PROVIDER. AFTER USING THE PRODUCT, I STARTED TO HAVE TROUBLE BREATHING AND CONSISTENT NASAL ISSUES. MY WIFE HAS ALSO EXPERIENCED GUM BLEEDING. I AM FURIOUS THAT THEY RECOMMENDED THE DEVICE CONSIDERING THE LACK OF FDA APPROVAL AND POTENTIAL ISSUES. I WAS NOT MADE AWARE OF THE ISSUES. I AM ALSO EXTREMELY CONCERNED THAT THIS POTENTIALLY PUTS MY WIFE AT GREATER RISK OF SERIOUS ISSUES. SHE HAS HEART FAILURE DUE TO ISSUES WITH HER LUNGS. ADDING "ACTIVATED OXYGEN" WITHOUT TELLING US THE RISKS COULD HAVE EXACERBATED THE HER PROBLEM. THEY ALSO HAVE THE FDA LOGO ON IT, MAKING IT SEEM APPROVED. AFTER CLOSER INSPECTION, IT SAYS FDA REGISTERED (B)(4). I UNDERSTAND THAT THEY ARE NOT SUPPOSED TO BE USING THE FDA LOGO. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854579 SOCLEAN 2 DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC. SC1200 18729300086

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO