BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN 2

    MDR report key: 19711558 · Received July 10, 2024

    Report

    Report Number
    3009534409-2024-00056
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 10, 2024
    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. REPORTING SYMPTOMS OF COUGH AND LUNG CONGESTION FOR DUE DILIGENCE. IT IS IMPORTANT TO NOTE THAT THE ETIOLOGY OF THE PULMONARY NODULE REMAINS UNDETERMINED, AND IT IS UNCLEAR IF THE REPORTED SYMPTOMS (COUGH AND PULMONARY CONGESTION) ARE SECONDARY TO THE PULMONARY NODULE. ADDITIONALLY, NO CANCER DIAGNOSIS HAS BEEN CONFIRMED. THE PATIENT HAS RETURNED THE DEVICE AND DISCONTINUED ITS USE. ANY UPDATED INFORMATION ON THE OUTCOME OF FUTURE TESTING WILL BE REPORTED TO THE FDA.

    Description of Event or Problem · 0

    CUSTOMER REPORTS LUNG CONGESTION AND COUGH. MD SEEN. CBC DONE WITH NO FINDINGS. CT SCAN WITH DYE CONTRAST FINDINGS PULMONARY NODULE FROM UNSPECIFIED ETIOLOGY FOUND. NO MEDICATION(S) RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354726 SOCLEAN 2 SLEEP EQUIPMENT MAINTENANCE SYSTEM LRJ SOCLEAN, INC. SC1200 00187293000860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other