BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY FEN. L-P-C 6-10.0

    MDR report key: 1251940 · Received December 3, 2008

    Report

    Report Number
    2936999-2008-00548
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    September 15, 2008
    Report Date
    November 3, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE. RETURN OF THE TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MFR WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE NEW OR SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TWIST LOCK OF AN LPC FEN DOESN'T WORK PROPERLY AFTER 3-4 DAYS. IT WAS REPORTED "IT GETS LOOSE". IT WAS REPORTED "THE PT REQUIRED MEDICAL INTERVENTION DUE TO THE TWIST LOCK AND IT WAS NECESSARY TO RE INTUBATE THE PT." IT WAS REPORTED THAT THE PACKAGE OF 6 LPC WAS THROWN AWAY. ONE LOT NUMBER WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FEN. L-P-C 6-10.0 NONE BTO COVIDIEN/FORMERLY TYCO HEALTHCARE 0803000481

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention