BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISP. CAN P-C 4-8.5 BXI

    MDR report key: 1543019 · Received November 20, 2009

    Report

    Report Number
    2936999-2009-00991
    Event Type
    Injury
    Date Received
    November 20, 2009
    Date of Event
    October 29, 2009
    Report Date
    October 29, 2009
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE CUFF WAS LEAKING, AND PATIENT WAS TAKEN TO THE ER WHERE THEY CHANGED THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP. CAN P-C 4-8.5 BXI TRACHEOSTOMY TUBE JOH COVIDIEN/ FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention