BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SO CLEAN 2

    MDR report key: 10566410 · Received September 21, 2020

    Report

    Report Number
    MW5096780
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    September 16, 2020
    Report Date
    September 17, 2020
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USE THE SO CLEAN 2 WHICH WAS PROMISED TO KILL 99.9% OF ALL GERMS, BACTERIA, AND MOLD ONLY TO FIND FUZZY MOLD GROWING IN THE WATER RESERVOIR EVEN THOUGH I USED THE SO CLEAN 2 EVERY DAY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029233 SO CLEAN 2 DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC. SO CLEAN 2

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other