BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN

    MDR report key: 9952851 · Received April 10, 2020

    Report

    Report Number
    MW5094101
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 8, 2020
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED THE SOCLEAN CPAP MACHINE CLEANER. HAVING BEEN USING AS DIRECTED FOR THE LAST 2 WEEKS AND I AM NOW EXPERIENCING SOME SHORTNESS OF BREATH AND EYE ISSUES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411230 SOCLEAN DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC. SC1200

    Patients

    Seq Age Sex Outcome Treatment
    1