BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3815723 · Received March 24, 2014

    Report

    Report Number
    2936999-2014-00272
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    SWEDEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS CURRENTLY IN TRANSIT TO OUR MFG SITE FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INNER CANNULA IS STUCK AND CANNOT MOVE. COVIDIEN IS ATTEMPTING TO GATHER ADD'L INFO RELATED TO THE CIRCUMSTANCES OF THIS REPORT AND ANY ASSOCIATED PT INVOLVEMENT. COVIDIEN IS ATTEMPTING TO GATHER ADD'L INFO RELATED TO THE CIRCUMSTANCES OF THIS REPORT AND ANY ASSOCIATED PT INVOLVEMENT RELATIVE TO CARE OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172907 SHILEY TEACHEOSTOMY TUBE JOH COVIDIEN 13D0860JZX

    Patients

    Seq Age Sex Outcome Treatment
    1