BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOX T3-OXIMETER

    MDR report key: 22329137 · Received June 24, 2025

    Report

    Report Number
    MW5171885
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    March 24, 2025
    Report Date
    June 13, 2025
    Manufacturer
    NOX MEDICAL
    Product Code
    MNR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON TUESDAY MORNING (B)(6) 2025, THE PARTICIPANT PICKED UP THE NOX DEVICE AND WAS INFORMED ON HOW TO USE AND PUT ON THE DEVICE. THE PARTICIPANT USED THE DEVICE THAT SAME NIGHT (B)(6) 2025 AND HOOKED UP THE DEVICE. THE PARTICIPANT STARTED THE DEVICE AND WENT TO BED AT 7:00 PM AND WOKE UP AT 2:15 AM IN THE MIDDLE OF THE NIGHT WITH A DESCRIBED BURNING SENSATION ON HIS LEFT INDEX FINGER, THE FINGER THAT WAS IN THE OXIMETER. HE TOOK OFF THE MACHINE AND SAW A BURNING MARK ON HIS LEFT INDEX FINGER. THE LEFT INDEX FINGER BURN HAS SINCE RESOLVED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873392 NOX T3-OXIMETER VENTILATORY EFFORT RECORDER MNR NOX MEDICAL 627-2150

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other