BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEUREVAC

    MDR report key: 585941 · Received March 18, 2005

    Report

    Report Number
    585941
    Event Type
    Malfunction
    Date Received
    March 18, 2005
    Date of Event
    March 8, 2005
    Report Date
    March 18, 2005
    Manufacturer
    GENZYME CORPORATION
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    ON ATTEMPT OF REMOVAL OF TWO LEFT CHEST TUBES BY THE PHYSICIAN ON THE NURSING UNIT, A PORTION OF ONE OF THE CHEST TUBES BROKE OFF IN THE LEFT PLEURAL SPACE REQUIRING THE PATIENT TO UNDERGO A LEFT THORACOTOMY FOR REMOVAL OF THE RETAINED PIECE. THE SECOND CHEST TUBE WAS REMOVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUREVAC THORACIC CATHETER KDQ GENZYME CORPORATION DSTC-285 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR