BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SO CLEAN 2

    MDR report key: 18484879 · Received January 9, 2024

    Report

    Report Number
    MW5150058
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    August 1, 2023
    Report Date
    January 6, 2024
    Manufacturer
    SO CLEAN / SOCLEAN, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY CPAP MACHINE RESERVOIR DEVELOPED BLACK DEPOSITS INSIDE THE RESERVOIR. I GOT A NEW CPAP RESERVOIR, BUT I WAS ADVISED BY MY CPAP SUPPLIER, DALE SESSIONS OF CPAP SOLUTIONS, HERE IN BUTTE, MT, TO DISCONTINUE USE OF THE SO CLEAN 2 MACHINE, UPC NUMBER 87293 00086. THEREFORE, I STOPPED USING MY SO CLEAN 2 MACHINE. REF REPORT: MW5150059.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887922 SO CLEAN 2 DISINFECTANT, MEDICAL DEVICES LRJ SO CLEAN / SOCLEAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female