BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THAL-QUICK CHEST TUBE TRAY

    MDR report key: 3093946 · Received April 26, 2013

    Report

    Report Number
    1820334-2013-00172
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(62 13, A FEMALE PATIENT WAS GIVEN MORPHINE AND THORACENTESIS WAS ATTEMPTED USING THE THAL-QUICK CHEST TUBE TRAY. UPON REMOVAL OF THE DEVICE GUIDEWIRE, DURING THE STAGE OF MULTIPLE DILATIONS, THE PATIENT HAD A SEIZURE. PATIENT STOPPED BREATHING, WHICH REQUIRED CPR. THE PATIENT IS NOW IN STABLE CONDITION. THE PHYSICIAN STATED THAT THE SEIZURE AND BREATHING APPEARS TO BE UNRELATED TO THE DEVICE. IT WAS ALSO NOTED BY THE REPORTER THAT THE LUNG X-RAY WAS A WHITE OUT ON THE LEFT SIDE, AND THE PHYSICIAN USED ULTRASOUND GUIDANCE FOR WIRE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181692 THAL-QUICK CHEST TUBE TRAY DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP[ Required Intervention