BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATMOSCLEAN

    MDR report key: 10312093 · Received July 22, 2020

    Report

    Report Number
    MW5095671
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    July 20, 2020
    Report Date
    July 20, 2020
    Manufacturer
    MASTER FX, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DOESN'T SANITIZE AS EXPECTED; THIS COMPANY IS CLAIMING WITHOUT EVIDENCE THAT THEIR SANITIZING LIQUID DELIVERY SYSTEM IS EFFECTIVE. ONLY THE LIQUID HAS BEEN PROVEN EFFECTIVE. THE FOGGING SYSTEM THAT CONVERTS THE LIQUID TO GASEOUS STATE WHICH THEN CONDENSES INTO TINY DROPLETS IN THE AIR, HAS NOT BEEN SHOWN TO BE EFFECTIVE AS CLAIMED. (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774053 ATMOSCLEAN DISINFECTANT, MEDICAL DEVICES LRJ MASTER FX, INC. ATMOSCLEAN VAPOR SANITIZING SYST NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other