BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH

    MDR report key: 25150303 · Received May 12, 2026

    Report

    Report Number
    MW5188039
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    May 3, 2025
    Report Date
    May 8, 2025
    Manufacturer
    BEACON BIO DX, LLC DBA CLEVEMED
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT'S MOM CALLED TO REPORT ISSUES WITH A SLEEP MONITORING DEVICE BEING USED BY HER DAUGHTER. DAUGHTER RENTED A SLEEP MONITORING DEVICE FROM (B)(6), A SLEEP CLINIC. PATIENT WAS SUPPOSE TO WEAR DEVICE FOR A FEW DAYS TO MONITOR SLEEP ACTIVITY/QUALITY. 3 DAYS INTO WEARING THE DEVICE, PATIENT STARTED TO EXPERIENCE SYMPTOMS OF ITCHY/SCRATCHY THROAT, WHICH DEVELOPED INTO A SOAR THROAT. MOM THINKS SINCE THIS IS A REFURBISHED DEVICE TRYING TO STERILIZE THE DEVICE CAN BE A CHALLENGE. MOM STATES THAT THE ONLY PIECE OF THE DEVICE THAT'S BRAND-NEW IS THE CANNULA. THE PATIENT EXPERIENCED THESE SAME SYMPTOMS IN 2024 WITH ANOTHER REFURBISHED DEVICE THAT ONLY HAD A NEW CANNULA. PATIENT WAS DIAGNOSED WITH HURLERS SYNDROME ABOUT THREE YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217113 FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH GWQ BEACON BIO DX, LLC DBA CLEVEMED

    Patients

    Seq Age Sex Outcome Treatment
    1