BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PERITONEAL CATHETER

    MDR report key: 905214 · Received July 31, 2007

    Report

    Report Number
    905214
    Event Type
    Malfunction
    Date Received
    July 31, 2007
    Date of Event
    July 26, 2007
    Report Date
    July 31, 2007
    Manufacturer
    DENVER BIOMEDICAL, INC.
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD TUNNELED PERITONEAL DRAIN PLACED FOR MALIGNANT ASCITES. DUE TO CONTINUED ABDOMINAL DISCOMFORT, PATIENT REQUESTED DRAIN BE REMOVED. RADIOLOGIST UNABLE TO REMOVE CATHETER, WHICH APPEARS TO BE TRAPPED IN PERITONEUM, POSSIBLY IN TUMOR. UNABLE TO CONTACT PRODUCT ENGINEER TO DETERMINE TENSILE STRENGTH; AND HOW AGGRESSIVELY TO ATTEMPT REMOVAL. CATHETER IS STILL IN PATIENT; IS FUNCTIONING AND HAS NOT CAUSED INJURY, BUT IS UNCOMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX PERITONEAL CATHETER CATHETER, PERITONEAL FJS DENVER BIOMEDICAL, INC. 50-8000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR