BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN 2

    MDR report key: 12957284 · Received December 7, 2021

    Report

    Report Number
    3009534409-2021-00476
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    November 22, 2021
    Report Date
    December 7, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    UDI-DI
    00187293000860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FILE A 30-DAY MDR. AN ASSESSMENT WAS CONDUCTED. THE EVENT IS STILL CONSIDERED REPORTABLE UNDER FDA'S REGULATION. IT WAS NOTED THAT THE CUSTOMER WAS JUST RECOVERING FROM COVID-19 AS WELL AS DOUBLE PNEUMONIA WHEN THEY BEGAN TO USE THE SOCLEAN DEVICE. IT IS NOT UNREASONABLE TO ASSUME THE CUSTOMER INJURY IS A RESULT OF THEIR PREVIOUS ILLNESS.

    Description of Event or Problem · 0

    CUSTOMER REPORTS A SORE THROAT, LOSE OF VOICE, LUNG INFECTION SYMPTOMS WITH MD INTERVENTION REQUIRING BRONCHOTOMY AND THROAT SCOPE WITH NSF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855188 SOCLEAN 2 SLEEP EQUIPMENT MAINTENANCE SYSTEM LRJ SOCLEAN, INC. SC1200 00187293000860

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention