BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SO CLEAN 2

    MDR report key: 19239131 · Received May 2, 2024

    Report

    Report Number
    MW5154495
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 18, 2024
    Report Date
    April 29, 2024
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THERE WAS A HUGE AMOUNT OF CARBON IN THE FILTER OF MY CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE. UNABLE TO RINSE CARBON OUT OF FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591659 SO CLEAN 2 DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC. SC120018010406667

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female ASPRIN 81MG.| ATORVASTATIN 10 MG.| CLARITIN PRN.| COLACE 300 MG.| D3 2000.| FLONASE.| LANSOPRAZOLE 30 MG.| LINZESS 72.| MULTIVITAMIN.| OSTEO BI FLEX 2 TABS.| PRO OMEGA 3-6-9 2 TABS.| RESTASIS EYE GTTS.| RISTASIS TWICE DAILY IN BOTH EYES.| SIMPLY SALINE DAILY.