BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 330308 · Received May 2, 2001

    Report

    Report Number
    1717671-2001-00003
    Event Type
    Malfunction
    Date Received
    May 2, 2001
    Date of Event
    April 6, 2001
    Report Date
    April 18, 2001
    Manufacturer
    DENVER BIOMEDICAL, INC.
    Product Code
    KPM
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED OF A CATHETER FRACTURE AT THE PARIETAL PLEURAL INSERTION SITE. THE ENTIRE CATHETER WAS REMOVED UNDER LOCAL ANESTHESIA USING BLUNT DISSECTION OF THE SUBCUTANEOUS TUNNEL. NO COMPLICATIONS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20145 PLEURX PLEURAL CATHETER KIT PLEURAL CATHETER KPM DENVER BIOMEDICAL, INC. 50-7000 R992479

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention