BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN2

    MDR report key: 12788117 · Received November 10, 2021

    Report

    Report Number
    3009534409-2021-00336
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 14, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    UDI-DI
    00187293000860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    ON THIS DATE (090221) SOCLEAN RECEIVED NOTIFICATION OF A SUS VOLUNTARY EVENT REPORT FOR MW5103299. FOLLOWING OUR REVIEW OF THE COMPLAINT RELATED TO (A COUGH), SOCLEAN HAS DETERMINED THAT A MEDICAL DEVICE REPORT (MDR) WAS REQUIRED FOR THIS EVENT. DEVELOPED A COUGH GRADUALLY OVER TIME. MD TOOK CHEST X-RAY. CONCOMITANT MEDICAL: HYDRALAZINE, METOPROLOL, LOSARTAN, ATORVASTATIN, ZETIA, LEVOTHYROXINE, VITAMIN D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684818 SOCLEAN2 D2 SLEEP EQUIPMENT MAINTENANCE SYSTEM LRJ SOCLEAN, INC. SC1200 00187293000860

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other