BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN2

    MDR report key: 19428296 · Received May 29, 2024

    Report

    Report Number
    MW5155569
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    February 28, 2024
    Report Date
    May 23, 2024
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CLEANER NO LONGER WOULD WORK AND DID NOT HAVE THE AVAILABILITY TO CONTACT YOU UNTIL NOW. LIGHT SHOWING MACHINE NOT WORKING PROPERLY. REPLACED FILTER, HOWEVER, STILL DID NOT WORK. PURCHASED AT A LOCAL DURABLE MEDICAL EQUIPMENT/PHARMACY SITE IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328743 SOCLEAN2 DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE. | KLONOPIN.| LYRICA.| PERIODICALLY: MELATONIN GUMMIES.| PERIODICALLY: TYLENOL WITH SLEEP AID.| PROPRANOLOL.| PROTONIX.| REQUIP.| WELLBUTRIN.| ZOLOFT.