BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEURX PLEURAL CATHETER

    MDR report key: 714699 · Received May 10, 2006

    Report

    Report Number
    1717671-2006-00001
    Event Type
    Other
    Date Received
    May 10, 2006
    Date of Event
    March 10, 2006
    Report Date
    March 28, 2006
    Manufacturer
    DENVER BIOMEDICAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FLEURX CATHETER CUFF MIGRATED OUT OF TUNNEL. CUFF HAD NOT GROWN IN, YET. PATIENT HAD PNEUMOTHORAX. SPOKE TO HEAD TECH IN INTERVENTIONAL RADIOLOGY. DR IN IR PLACED CATHETER. HEAD TECH SADI THAT THE PATIENT HAD A PNEUMOTHORAX PRIOR TO INSERTION OF THE PLEURX CATHETER. HE BELIEVED THAT THAT THE LATER PNEUMOTHORAX WAS FROM THE SAME CAUSE (PROBABLY AN AIR LEAK IN THE LUNGH) AND NOT DUE TO THE CATHETER. CATHETER WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX PLEURAL CATHETER IMPLANTABLE TUNNELED CATHETER DZE DENVER BIOMEDICAL, INC. 50-7000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other