BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN 2

    MDR report key: 21363488 · Received February 11, 2025

    Report

    Report Number
    MW5165983
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    February 14, 2023
    Report Date
    February 5, 2025
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SOCLEAN 2 BREATHING ISSUES FOLLOWING USE. USED CPAP RESMED AIRSENSE10 IN EVENING FOLLOWING SOCLEAN 2 "CLEANING". COUGHING AND SHORTNESS OF BREATH NEXT MORNING. TRIED AGAIN ONE WEEK LATER AND RAN CPAP FOR ABOUT EIGHT HOURS AFTER "CLEANING" IN ATTEMPT TO REMOVE PUNGENT OZONE ODOR WITH NO SUCCESS. I HAVEN'T USED IT SINCE. MY FATHER EXPERIENCED SIMILAR ISSUES. I HAVE BOTH SOCLEAN 2 UNITS IN MY POSSESSION. I/WE WERE NEVER CONTACTED REGARDING ANY RECALL. THEY WERE PURCHASED NEW, NOT USED. REF REPORT: MW5165984.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163886 SOCLEAN 2 DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC. SC 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Disability CITALOPRAM HBR 40MG | AMLODOPINE BESYLATE 10MG | MATURE MULTI NATURE MADE B-COMPLEX WITH C NATURE MADE D3 200 IU (50MCG)| OLMESARTAN MEDOXOMIL 40MG | OMEPRAZOLE DR 40MG | PROPANOLOL 20MG AM & PM | RESMED AIRSENSE 11| SIMVASTATIN 5 MG | TESTOSTERONE CYPIONATE 200MG/ML 0.5 CC INJECTION WEEKLY