BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 2932301 · Received January 24, 2013

    Report

    Report Number
    2936999-2013-00009
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 28, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALLER INDICATED THAT THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED TO THE MANUFACTURING SITE FOR ANALYSIS BUT HAS YET TO BE RECEIVED. IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE SAMPLE ANALYSIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CALLER STATES THAT THE TRACH THAT WAS PLACED IN THE PT ON (B)(6) 2012 STARTED TO LOSE AIR WITHIN A WEEK AND WAS REPLACED ON (B)(6) 2012. CALLER STATES THAT THE PILOT BALLOON IS INFLATED THEN IT DEFLATES DURING THE NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34786 SHILEY DISPOSABLE CANNULA FENESTRATED LOW JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 1210228JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention