BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE INTRO-TIP CURVED UNIVERSAL DRAINAGE CATHETER

    MDR report key: 2953848 · Received January 31, 2013

    Report

    Report Number
    1820334-2013-00056
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 28, 2012
    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. SEPARATE IS NOT LABELED. EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    INFO WAS INITIALLY PROVIDED THAT USER EXPERIENCED FAILURE OF A 6FR CATHETER. ADD'L INFO REC'D ON (B)(6) 2013 - LUER HUB POLLED OFF ON WARD. THE PT HAD ADVERSE EFFECTS DUE TO THIS OCCURRENCE AS THE PT HAD A PNEUMOTHORAX. MULTIPLE ATTEMPTS TO GATHER ADD'L INFO HAS BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42037 ULTRATHANE INTRO-TIP CURVED UNIVERSAL DRAINAGE CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA 3692438

    Patients

    Seq Age Sex Outcome Treatment
    1 Other