BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN

    MDR report key: 19258771 · Received May 6, 2024

    Report

    Report Number
    MW5154592
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 6, 2024
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLING, STATING HIS GIRLFRIEND HAS "LIFE-THREATENING" INJURIES DUE TO HEALTH PROBLEMS AFTER USING SOCLEAN WITH HER RESMED CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) DEVICE. REPORTER STATES HIS GIRLFRIEND EXPERIENCED BURNING SENSATION IN HER LUNGS AND AFTER SUBSEQUENT TRIP TO THE EMERGENCY ROOM WAS DIAGNOSED WITH PNEUMONIA. REPORTER STATES HE LEARNED OF THE SOCLEAN RECALL ONLINE AFTER THE FACT AND WAS NEVER NOTIFIED AHEAD OF TIME REGARDING THE PROBLEMS WITH OZONE CLEANERS. REPORTER STATES THERE ARE NO WARNING LABELS ON ANY OF THE SOCLEAN MATERIALS AND THAT HER CPAP DEVICE EMITS STRONG ODORS. REPORTER STATES HIS GIRLFRIEND WAS HOSPITALIZED AT "(B)(6) HOSPITAL, IN (B)(6)". REPORTER ADDITIONALLY STATES HE ALSO USES SOCLEAN WITH HIS CPAP MACHINE AND HAS CONCERNS REGARDING THE CHEMICAL ODOR HIS DEVICE EMITS AFTER SOCLEAN USE. REPORTER STATES HE IS CONCERNED ABOUT THE SOCLEAN RECALL AND HOW IT MAY IMPACT HIS HEALTH. REFERENCE REPORTS: MW5154589, MW5154590, MW5154591.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175133 SOCLEAN DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male RESMED CPAP.