BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE INTRO-TIP DESIGN CURVED UNIVERSAL DRAINAGE CATHETER

    MDR report key: 2953845 · Received January 31, 2013

    Report

    Report Number
    1820334-2013-00057
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PNEUMOTHORAX IS NOT LABELED. SEPARATES IS NOT LABELED. EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH MODERATE LEFT PLEURAL EFFUSION UNDERWENT LEFT THORACENTESIS. THE HUB OF THE CATHETER PULLED OFF ON WARD. THE PT UNDERWENT A CHEST X-RAY. THE PT DEVELOPED A SIGNIFICANT HYDRO/PNEUMOTHORAX BEFORE THE TUBE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42235 ULTRATHANE INTRO-TIP DESIGN CURVED UNIVERSAL DRAINAGE CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA 3692438

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other