BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN 2

    MDR report key: 12708361 · Received October 27, 2021

    Report

    Report Number
    3009534409-2021-00114
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    December 11, 2020
    Report Date
    July 12, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    UDI-DI
    00187293000860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FILE A 30-DAY MDR. AN ASSESSMENT WAS CONDUCTED. THE EVENT IS STILL CONSIDERED REPORTABLE UNDER FDA'S REGULATION. SOCLEAN HAS REVIEWED AND MADE IMPROVEMENTS TO THE COMPLAINT HANDLING PROCEDURE TO ENSURE COMPLIANCE WITH FDA REGULATIONS. THESE IMPROVEMENTS WERE RECOMMENDED BECAUSE OF AN INTERNAL AUDIT CONDUCTED BY AN EXTERNAL INDEPENDENT REGULATORY CONSULTANT. SOCLEAN OPENED SEVERAL CAPAS TO REMEDIATE THE AUDIT FINDINGS. PROCESSES WERE REVISED TO ENSURE REPORTABLE EVENTS WERE CORRECTLY IDENTIFIED AND SUBMITTED TO FDA. PER FDAS GUIDANCE, SOCLEAN IS NOW REPORTING THESE EVENTS, WHICH ALSO INCLUDES RETROSPECTIVE ITEMS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS AN INABILITY TO WALK, DYSPNEA AND CHEST PAIN DUE TO INFLAMMATION AROUND HEART AND LUNGS WITH MD INTERVENTION REQUIRING ER VISIT, HOSPITALIZATION, OXYGEN THERAPY, AND INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604979 SOCLEAN 2 SLEEP EQUIPMENT MAINTENANCE SYSTEM LRJ SOCLEAN, INC. SC1200 00187293000860

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R