BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN2

    MDR report key: 19809523 · Received July 22, 2024

    Report

    Report Number
    MW5157480
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    November 28, 2019
    Report Date
    July 17, 2024
    Manufacturer
    SOCLEAN INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT A SOCLEAN2 CPAP DISINFECTOR. IT WAS NOT ANYTHING LIKE IT WAS ADVERTISED IT CAME WITH A CHEMICAL AND WE WERE AFRAID TO USE DUE TO THE CHEMICAL. RECENTLY I FOUND OUT THAT THE MACHINE DOES NOT DISINFECT AS ADVERTISED AND IS DANGEROUS TO HUMANS. I ASKED COMPANY TO RETURN THE PURCHASE PRICE BUT THEY R REFUSING STATING WE SHOULD HAVE RETURNED IT RIGHT AFTER WE BOUGHT IT. I DID NOT KNOW UNTIL RECENTLY THAT IT DIDN'T CLEAN AS ADVERTISED AND THAT'S ITS DANGEROUS TO USE. I WANT TO KNOW IS THERE ANY RECOURSE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358685 SOCLEAN2 DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN INC. SC2019

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other I USE A VARIETY OF PSYCHOTROPIC MEDICATIONS AND VITAMINS.| I'VE SINCE BOUGHT A SAFE CPAP CLEANER AND AM HAPPY WITH IT.