BEUDAMED
    FDA Adverse Event Summary report: N

    CURAPLEX NASOPHARYNGEAL AIRWAY

    MDR report key: 11848000 · Received May 18, 2021

    Report

    Report Number
    MW5101415
    Date Received
    May 18, 2021
    Report Date
    May 16, 2021
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    BTQ
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CURAPLEX BRAND NASOPHARYNGEAL AIRWAY MIGRATED INTO THE PATIENT'S NASAL PASSAGE DUE TO A POORLY DESIGNED FLANGE ON THE PROXIMAL END OF THE AIRWAY, DESIGNED TO PREVENT THIS FROM HAPPENING. THE FLANGE IS TOO SMALL, AND THE AIRWAY CAN (AND DID) SLIDE INTO THE NOSE REQUIRING REMOVAL WITH KELLY FORCEPS IN THE EMERGENCY DEPARTMENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737697 CURAPLEX NASOPHARYNGEAL AIRWAY AIRWAY, NASOPHARYNGEAL BTQ BOUND TREE MEDICAL, LLC 51156 1501518

    Patients

    Seq Age Sex Outcome Treatment
    1