BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN2 BOI

    MDR report key: 22588080 · Received July 24, 2025

    Report

    Report Number
    MW5173220
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Report Date
    July 20, 2025
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NUMEROUS SINUS INFECTIONS WHILE USING SOCLEAN2 AND NOW CONTINUES TO BE A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988328 SOCLEAN2 BOI DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC. SOCLEAN2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male JARDIANCE| B-12| GABAPENTIN| GEMFIBROZIL| LANTUS| METFORMIN| MULTI VITAMIN | NUVIGIL| OMEPRAZOLE| OZEMPIC| PRAMIPEOLE | PROPANOLOL| RESMED S10 BIPAP| ROSUVASTATIN| ZYRTEC