BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEURX CATHETER MINI KIT

    MDR report key: 721591 · Received June 1, 2006

    Report

    Report Number
    1717671-2006-00002
    Event Type
    Injury
    Date Received
    June 1, 2006
    Date of Event
    May 2, 2006
    Report Date
    May 30, 2006
    Manufacturer
    DBI
    Product Code
    KPM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED A SURGICAL EMPHYSEMA, INDICATING THE UNDERLYING LUNG HAD TORN AND WAS LEAKING AIR APPROXIMATELY ONE WEEK AFTER PLUREX CATHETER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX CATHETER MINI KIT PLEURAL DRAINAGE TUBE KPM DBI 50-7050 9051

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization