BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY XLT

    MDR report key: 3132920 · Received May 23, 2013

    Report

    Report Number
    2936999-2013-00387
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K051416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A CUSTOMER REPORT THAT THE CUFF OF THE DEVICE WOULD NOT HOLD AIR. THE CUSTOMER REPORTED THIS WAS DISCOVERED DURING PT RESULTING IN DECANNULATION / RECANNULATION OF A REPLACEMENT TUBE. THE CUSTOMER DID NOT PROVIDE ANY FURTHER DETAILS AND CONFIRMED THAT PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228393 SHILEY XLT EXTENDED-LENGTH TRACHEOSTOMY TUBE JOH COVIDIEN 201210014X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention