BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENAX LASER SAFE ENDOTRACHEAL TUBE

    MDR report key: 23532909 · Received November 12, 2025

    Report

    Report Number
    MW5178742
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 6, 2025
    Manufacturer
    BRYAN MEDICAL INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE BALLOONS OF LASER SAFE TUBE COULD NOT BE FILLED WITH SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140089 TENAX LASER SAFE ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR BTR BRYAN MEDICAL INC. TG0050-S 1407503A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other