BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY FEN LPC

    MDR report key: 1063252 · Received June 18, 2008

    Report

    Report Number
    2936999-2008-00263
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 20, 2008
    Manufacturer
    COVIDIEN/ FORMERLY TYCO
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MANUFACTURER WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED, AND FAILURE INVESTIGATION RESULTS PROVIDE SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE NURSE WHO WAS LOOKING AFTER THE PT SAID THAT SHE CHECKED CUFF PRESSURES AND IT REMAINED AT 30 CM OF H2O. THE PT WAS NOT VENTILATING WELL AND STARTED TO DEVELOP SURGICAL EMPHYSEMA. THE TRACHEOSTOMY WAS THEN REMOVED AND THEY NOTICED THAT THE CUFF HAD HERNIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FEN LPC TRACHEOSTOMY TUBE BTO COVIDIEN/ FORMERLY TYCO FEN LPC 0708000208

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention