BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER HI-LO 7.0MM

    MDR report key: 1584263 · Received January 19, 2010

    Report

    Report Number
    2936999-2009-01232
    Event Type
    Injury
    Date Received
    January 19, 2010
    Date of Event
    November 1, 2009
    Report Date
    December 21, 2009
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K965132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE CALLER REPORTED EXPERIENCING DIFFICULTY WITH SECRETIONS STICKING TO THE SIDES OF THE ENDOTRACHEAL TUBE, SOMETIME OVER THE PAST TWO MONTHS. THE PT REQUIRED A NON-ROUTINE REPLACEMENT OF THE TUBE. THE TUBE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTER HI-LO 7.0MM ENDOTRACHEAL TUBE BTR COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention