BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN

    MDR report key: 12682022 · Received October 21, 2021

    Report

    Report Number
    MW5104871
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    July 20, 2020
    Report Date
    October 19, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A SOCLEAN MACHINE FOR MY CPAP MACHINE AND I HAVE NOTICED BEING MORE CONGESTED AND COUGHING IN THE MORNINGS AFTER USING IT AND BEING IN MY ROOM. I HAVE TRAVELED AND NOT TAKEN THE SOCLEAN AND HAVE NOT HAD THE PROBLEM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568133 SOCLEAN DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC. 2

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR