BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL RAE

    MDR report key: 1643843 · Received March 25, 2010

    Report

    Report Number
    2936999-2010-00577
    Event Type
    Injury
    Date Received
    March 25, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 26, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K941246
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TUBE FAILED WITH A CUFF LEAK. A NON-ROUTINE REPLACEMENT OF THE TUBE WAS REQUIRED. THE TUBE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASAL RAE NASAL, TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention