BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN 2

    MDR report key: 12643958 · Received October 17, 2021

    Report

    Report Number
    3009534409-2021-00124
    Event Type
    Injury
    Date Received
    October 17, 2021
    Date of Event
    November 2, 2020
    Report Date
    July 13, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    UDI-DI
    00187293000860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 OUR COMPLAINT HANDLING PROCEDURE TO ENSURE COMPLIANCE WITH FDA REGULATIONS. THESE IMPROVEMENTS WERE RECOMMENDED AS A RESULT OF AN INTERNAL AUDIT CONDUCTED BY AN EXTERNAL INDEPENDENT REGULATORY CONSULTANT. WE REVISED OUR DECISION TREES AND RE-EVALUATED RETROSPECTIVE COMPLAINTS TO ENSURE REPORTABLE EVENTS WERE CORRECTLY IDENTIFIED. PER FDAS GUIDANCE SOCLEAN IS NOW REPORTING THESE RETROSPECTIVE MDRS. IN ADDITION, SOCLEAN HAS OPENED SEVERAL CAPA'S TO REMEDIATE THE AUDIT FINDINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A RASH WITH MD INTERVENTION REQUIRING AN ANTIBIOTIC OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542105 SOCLEAN 2 SLEEP EQUIPMENT MAINTENANCE SYSTEM LRJ SOCLEAN, INC. SC1200 00187293000860

    Patients

    Seq Age Sex Outcome Treatment
    1 Other