BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN 2

    MDR report key: 13685276 · Received March 7, 2022

    Report

    Report Number
    3009534409-2022-00513
    Event Type
    Injury
    Date Received
    March 7, 2022
    Date of Event
    February 15, 2022
    Report Date
    February 28, 2022
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    UDI-DI
    00187293000860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    THE CUSTOMER REPORTS A LUNG NODULE, PNA, ACUTE RESPIRATORY FAILURE SECONDARY TO LUNG INFECTION IN HIS LLL. THE CUSTOMER HAD UNSPECIFIED TESTING AND A HOSPITALIZATION REQUIRING ANTIBIOTICS TO TREAT HIS PNA. IN ADDITION THIS CUSTOMER STATES PREEXISTING EMPHYSEMA AND WAS NOT FOLLOWING INSTRUCTIONS FOR PROPER MAINTENANCE AS SPECIFIED IN OUR IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166914 SOCLEAN 2 SLEEP EQUIPMENT MAINTENANCE SYSTEM LRJ SOCLEAN, INC. SC1200 00187293000860

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| O