BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURE

    MDR report key: 21796641 · Received April 8, 2025

    Report

    Report Number
    21796641
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    January 25, 2025
    Report Date
    April 2, 2025
    Manufacturer
    ENDURE INDUSTRIES, INC
    Product Code
    BTQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DELAY IN RECOGNITION OF RETAINED NASOPHARYNGEAL AIRWAY (NPA) PLACED PRIOR TO ADMISSION CAUSING BLEEDING, SWELLING, NEED FOR EMERGENT TRACH WHEN PATIENT WAS EXTUBATED AND REQUIRED REINTUBATION. NPA WAS CLEAR AND HAS NO RADIOPAQUE STRIP MAKING IT MORE DIFFICULT TO RECOGNIZE BOTH VISUALLY AND RADIOGRAPHICALLY. UNABLE TO IDENTIFY MANUFACTURER OR ANY DEVICE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754406 ENDURE AIRWAY, NASOPHARYNGEAL BTQ ENDURE INDUSTRIES, INC NPS3021217

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R