BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN 2 CPAP CLEANER AND SANITIZER

    MDR report key: 12130212 · Received July 6, 2021

    Report

    Report Number
    MW5102318
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    November 1, 2017
    Report Date
    July 1, 2021
    Manufacturer
    SoClean Inc.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CHRONIC COUGH SINCE; I BEGAN TO NOTICE I HAD A COUGH. I HAVE ASTHMA AND HAVE SPENT COUNTLESS DOLLARS AND TIME AT THE ALLERGIST AND AT THE PULMONOLOGISTS OFFICE TRYING TO FIGURE OUT WHAT IS CAUSING THE COUGH. I JUST STARTED A REGIMEN OF 40 MG A DAY OF PREDNISONE, DECREASING SLOWLY. IF IT IS BEING CAUSED BY USE OF OZONE CLEANING PRODUCTS THEN I GUESS I SHOULD DISCONTINUE USE AND SEE IF THAT MAKES A DIFFERENCE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021033 SOCLEAN 2 CPAP CLEANER AND SANITIZER DISINFECTANT, MEDICAL DEVICES LRJ SoClean Inc.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other