BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SO CLEAN

    MDR report key: 12050235 · Received June 22, 2021

    Report

    Report Number
    MW5102046
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 23, 2019
    Report Date
    June 18, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I GOT A NEW CPAP MACHINE AND AT THIS TIME I DECIDED TO GET THE SO CLEAN MACHINE TO KEEP IT SANITIZED. IT WAS BEING ADVERTISED AS BEING VERY EFFECTIVE AND REPLACED THE RIGOROUS CLEANING NEEDED. AFTER 5 MONTHS OF USE I STARTED HAVING SHORTNESS OF BREATH, CHRONIC COUGH, DRY THROAT, LUNG INFLAMMATION. I THEN WAS SENT TO A PULMONOLOGIST HAD MANY TEST. I DID HAVE MILD ASTHMA AT THAT TIME THE TESTING SHOWED. STARTED ON MEDS FOR IT. ALSO HAD ENDOSCOPY. ECHO CARDIO GRAM. AFTER MONTHS OF TREATMENT DR HAVE STILL NOT FOUND THE CAUSE OF MY CHRONIC COUGH. I RAN ACROSS A RECALL ON MY CPAP AND THAT LED ME TO AN ISSUE AND COMPLAINTS BY MANY USER OF THE SO CLEAN. MANY OF THEIR SYMPTOMS WERE SAME AS MINE FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935767 SO CLEAN DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability