BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX

    MDR report key: 3407028 · Received October 11, 2013

    Report

    Report Number
    1045254-2013-00537
    Event Type
    Injury
    Date Received
    October 11, 2013
    Report Date
    September 18, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 7MM EMG FLEX TUBE ((B)(4), LOT#73178000, MFR DATE 06/2011); 6MM EMG FLEX TUBE (ID#8229960 LOT#73374400 MFR DATE 06/2011). (B)(4): NO DEVICES WERE RETURNED FOR EVALUATION. METHOD - NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO YEARS AGO, THERE WAS PATIENT ¿HARM/INJURY; OUTCOME: THE PATIENT ONLY RECOVERED AFTER 20 DAYS IN THE SICU.¿ THE EVENT INVOLVED THREE ENDOTRACHEAL TUBES (SIZES 6MM, 7MM, AND 8MM). THE INITIAL REPORTER CLAIMS THE INFORMATION AND DETAILS FOR THE EVENT ARE CONFIDENTIAL. NO FURTHER INFORMATION WAS PROVIDED OR AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522732 ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229980 72782700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization