BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN 2

    MDR report key: 12788456 · Received November 10, 2021

    Report

    Report Number
    3009534409-2021-00401
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    September 24, 2021
    Report Date
    October 4, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    UDI-DI
    00187293000860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. 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 · 0

    ON THIS DATE (09/24/2021) SOCLEAN RECEIVED NOTIFICATION OF A SUS VOLUNTARY EVENT REPORT FOR MW5103829. FOLLOWING OUR REVIEW OF THE COMPLAINT RELATED TO (COUGH), SOCLEAN HAS DETERMINED THAT A MEDICAL DEVICE REPORT (MDR) WAS REQUIRED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689812 SOCLEAN 2 SLEEP EQUIPMENT MAINTENANCE SYSTEM LRJ SOCLEAN, INC. SC1200 00187293000860

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other