BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN 2

    MDR report key: 13026753 · Received December 17, 2021

    Report

    Report Number
    3009534409-2021-00481
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    December 7, 2021
    Report Date
    December 13, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    UDI-DI
    00187293000860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 BELIEVES THIS COMPLAINT IS RELATED TO THE PHILIPS RECALL OF THE DREAMSTATION 1, NOT THE SOCLEAN DEVICE. SOCLEAN IS PROCESSING THIS COMPLAINT IN ACCORDANCE WITH ITS COMPLAINT HANDLING AND QUALITY SYSTEM PROCESSES.

    Description of Event or Problem · 0

    CUSTOMER REPORTS A RESPIRATORY ISSUE WITH MD INTERVENTION REQUIRING HOSPITALIZATION WITH IV ANTIBIOTICS, ALLERGY TESTING DONE WITH NSF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926427 SOCLEAN 2 SLEEP EQUIPMENT MAINTENANCE SYSTEM LRJ SOCLEAN, INC. SC1200 00187293000860

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization