BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACHEOSTOMY TUBE

    MDR report key: 8973405 · Received September 8, 2019

    Report

    Report Number
    8040459-2019-00095
    Event Type
    Injury
    Date Received
    September 8, 2019
    Date of Event
    March 31, 2014
    Report Date
    September 8, 2019
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    PMA / PMN Number
    K051416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE UNANTICIPATED DIFFICULT NASOTRACHEAL EXTUBATION FOLLOWING ORAL SURGERY SOURCE ACTA ANAESTHESIOLOGICA TAIWANICA VOLUME 52, 2014 (197-200). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, POSTOPERATIVELY, THE PATIENT HAD UNEXPECTED POSTOPERATIVE DIFFICULT NASOTRACHEAL EXTUBATION BY A KIRSCHNER PIN AND PENETRATED THE TUBE AND FIXING THE TUBE AT THE MAXILLARY BONE FOLLOWING TUMOR RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767063 TRACHEOSTOMY TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 8670

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention