BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURKEL SAFETY THORACENTESIS SYSTEM-SINGLE

    MDR report key: 275761 · Received April 27, 2000

    Report

    Report Number
    1282497-2000-00003
    Event Type
    Malfunction
    Date Received
    April 27, 2000
    Date of Event
    March 27, 2000
    Report Date
    April 27, 2000
    Manufacturer
    PHOENIX MEDICAL PRODUCTS
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    KENDALL HEALTHCARE REC'D REPORT FROM KENDALL AUSTRALIA ON 03/27/00, THAT DURING A THORACENTESIS PROCEDURE AIR WAS NOTED TO BE LEAKING INTO THE PLEURAL SPACE OF PT. NO PT INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURKEL SAFETY THORACENTESIS SYSTEM-SINGLE THORACENTESIS CATHETER GAA PHOENIX MEDICAL PRODUCTS 8888566034 00194191

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other