BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK AIRWAY EXCHANGE CATHETER

    MDR report key: 1050308 · Received May 22, 2008

    Report

    Report Number
    1820334-2008-00263
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 25, 2008
    Manufacturer
    COOK, INC.
    Product Code
    KTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AIRWAY EXCHANGE CATHETER TIP BROKE OFF WHILE IN THE PT'S LUNG. FRAGMENTS WERE RETRIEVED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK AIRWAY EXCHANGE CATHETER KTI SPECIAL SET KTI COOK, INC. NA 1846187

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention