BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN

    MDR report key: 20155913 · Received September 5, 2024

    Report

    Report Number
    MW5159211
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    September 4, 2024
    Report Date
    September 4, 2024
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED TO NOTIFY THE FDA THAT WHEN HE USES THE SOCLEAN PRODUCT, THERE IS AN OZONE ODOR THAT OCCURS WHILE IN USE. THE PRODUCT IS SUPPOSED TO BE FRAGRANCE-FREE AND NEUTRALIZE ODORS, WHICH IS NOT HAPPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073086 SOCLEAN DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Other