BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENVER BIOMEDICAL PLEURX CATHETER

    MDR report key: 422895 · Received October 17, 2002

    Report

    Report Number
    MW1026474
    Event Type
    Injury
    Date Received
    October 17, 2002
    Date of Event
    October 16, 2002
    Report Date
    October 17, 2002
    Manufacturer
    DENVER BIOMEDICAL, INC.
    Product Code
    KPM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WITH HISTORY OF LUNG CANCER AND HYPERTENSION. HAD A RIGHT PLEURAL EFFUSION. DURING PROCEDURE OF INSERTING PLEURX CATHETER PT DEVELOPED A PNEUMOTHORAX WITH SUBCUTANEOUS EMPHYSEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENVER BIOMEDICAL PLEURX CATHETER CHEST DRAINAGE TUBE KPM DENVER BIOMEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization