BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2051141 · Received April 5, 2011

    Report

    Report Number
    2936999-2011-00255
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 8, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BULB ON A 6DCT TRACHEOSTOMY TUBE WAS NOT INFLATING EVENLY, RESULTING IN A MISSHAPEN BULB. THE PT WAS RECANNULATED BEFORE THE ROUTINE TRACHEOSTOMY CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1007001624

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention