BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK PNEUMOTHORAX SET

    MDR report key: 1813056 · Received August 18, 2010

    Report

    Report Number
    1820334-2010-00386
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 19, 2010
    Manufacturer
    COOK INC
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EXP - UNK AS LOT IS UNK. (B)(4): NO EFFECT TO PATIENT WAS NOTED. (B)(4): DEVICE FALLING APART IS NOT LABELED. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PNEUMOTHORAX TUBE FELL APART WHILE IN THE PATIENT'S CHEST. THE TUBE WAS SUTURED AND STAYED IN PLACE ALLOWING THE PHYSICIAN TO REMOVE THE TUBE. PATIENT DID NOT HAVE PNEUMOTHORAX AFTER REMOVAL OF THE TUBE. A CHEST X-RAY WAS PERFORMED FOLLOWING TUBE REMOVAL AND THE PHYSICIAN PLANS TO FOLLOW-UP. THERE WERE NO ADVERSE EFFECTS UPON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK PNEUMOTHORAX SET DQR CANNULA, CATHETER DQR COOK INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR