BEUDAMED
    FDA Adverse Event Summary report: N

    CURAPLEX

    MDR report key: 9859916 · Received March 20, 2020

    Report

    Report Number
    9859916
    Date Received
    March 20, 2020
    Date of Event
    December 5, 2019
    Report Date
    February 4, 2020
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    BTQ
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NASOPHARYNGEAL AIRWAY WAS FOUND IN A PATIENT AND THE AIRWAY DOES NOT HAVE ANY IDENTIFYING INFORMATION. IT IS A GREEN SOFT PLASTIC LOOKING TUBE WITH 28FR ON THE SIDE AND SMALL CIRCLE. ACCORDING TO THE PICTURES OF THE CURAPLEX BY BOUND TREE NASOPHARYNGEAL AIRWAY, IT IS SIMILAR IN APPEARANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324650 CURAPLEX NASOPHARYNGEAL AIRWAYS BTQ BOUND TREE MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 28835 DA