BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-LO

    MDR report key: 2201967 · Received August 4, 2011

    Report

    Report Number
    2936999-2011-00459
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK THEREFORE, THE DATE OF MFR CAN NOT BE DETERMINED. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG SITE FOR INVESTIGATION. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE REPORTER STATED: THE TUBE WAS INSERTED IN THE OPERATING ROOM. THERE WAS DIFFICULTY IN VENTILATING THE PT. THE TUBE WAS REMOVED AND FOUND TO BE HERNIATED. A SECOND TUBE WAS INSERTED AND THE PROCEDURE WAS COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention