BEUDAMED
    FDA Adverse Event Summary report: N

    SOCLEAN 2

    MDR report key: 11912835 · Received May 28, 2021

    Report

    Report Number
    MW5101640
    Date Received
    May 28, 2021
    Date of Event
    May 27, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED A SOCLEAN 2 LAST NIGHT. IT DISINFECTED AT 10:00AM ON (B)(6) 2021 AND I WENT TO BED AT 10:00PM AND WHEN I PUT THE MASK ON IT HAD A STRONG ODOR. I PUT THE MASK ON AND EVENTUALLY THE SMELL WENT AWAY. USED MY CPAP MACHINE THROUGH THE NIGHT. THE NEXT DAY, I WAS HAVING TROUBLE BREATHING AND MY LUNGS DON'T FEEL RIGHT. I USED ONE TIME AND MY BREATHING IS TERRIBLE. I AM NEEDING AN INHALER. I AM RETURNING THE PRODUCT TO APRIADIRECT WHERE I PURCHASED IT FROM. I CALLED THEM AND TOLD THEM WHAT HAPPENED AND I NEED TO RETURN IT. THEY JUST WANTED TO SELL ME A DIFFERENT MACHINE. I WILL CLEAN IT MYSELF GOING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801318 SOCLEAN 2 DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR