BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2030479 · Received March 18, 2011

    Report

    Report Number
    2936999-2011-00132
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    December 1, 2009
    Report Date
    February 18, 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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK THEREFORE, THE DATE OF MANUFACTURE CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A LETTER DATED (B)(6) 2011 WHICH ALLEGED A PT TREATED AT (B)(6) SUFFERED SERIOUS INJURY ON TWO OCCASIONS. THE LETTER ALLEGES THE PT'S INJURIES OCCURRED AS A RESULT OF TWO SHILEY 8DCT TRACHEOSTOMY TUBES. ONE OCCASION WAS REPORTED AS OCCURRING IN LATE (B)(6) 2009. THE SECOND TUBE AND INJURY IS REPORTED ON RELATED REPORT NUMBER 2936999-2011-00135.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1