BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 125064 · Received October 3, 1997

    Report

    Report Number
    125064
    Event Type
    Injury
    Date Received
    October 3, 1997
    Date of Event
    June 19, 1996
    Report Date
    September 30, 1997
    Manufacturer
    ALLEGIANCE HEALTHCARE
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT THORACENTESIS ON JUNE 14, 15, 1996. CT SCAN ON JUNE 18 SHOWED FOREIGN BODY IN THE PLEURAL SPACE WHICH WAS A SEGMENT OF THE THORACENTESIS CATHETER. CATHETER TIP REMOVED BY INTERVENTIONAL RADIOLOGY PROCEDURE ON 06/19/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * THORACENTESIS CATHETER KDQ ALLEGIANCE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R