BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN INC.

    MDR report key: 13450266 · Received February 4, 2022

    Report

    Report Number
    3009534409-2022-00498
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    January 14, 2022
    Report Date
    February 2, 2022
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    UDI-DI
    00858242007147
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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.

    Description of Event or Problem · 0

    CUSTOMER REPORTS CONTACT DERMATITIS, SKIN BREAKDOWN WITH MD INTERVENTION REQUIRING MD ADVISED TO DC USE OF DEVICE AND RECEIVED STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849016 SOCLEAN INC. SLEEP EQUIPMENT MAINTENANCE SYSTEM LRJ SOCLEAN, INC. SC1400 00858242007147

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other