BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC XOMED

    MDR report key: 521378 · Received April 5, 2004

    Report

    Report Number
    MW1031766
    Event Type
    Injury
    Date Received
    April 5, 2004
    Date of Event
    March 31, 2004
    Report Date
    April 5, 2004
    Manufacturer
    MEDTRONIC XOMED
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT INTUBATED WITH NIM E.M.G ENDOTRACHEAL TUBE, REINFORCED FOR SURGICAL INTERVENTION OF EVACUATION, OF HEMATOMA. S/P PARATHYROIDECTOMY THE DAY PRIOR. DECISION TO KEEP PT INTUBATED ONE NIGHT DUE TO SWELLING. THE METAL USED FOR THE REINFORCEMENT BECAME FRAYED OCCLUDING LUMEN CAUSING DIFFICULTY IN SUCTIONING REQUIRED REMOVAL AND TRACH THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC XOMED NIM EMG ENDOTRACHEAL TUBE BTR MEDTRONIC XOMED 8229307 32779200

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| O| R