BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM TRAUM ANGLE SILICONE CATHETER

    MDR report key: 16973 · Received July 29, 1994

    Report

    Report Number
    16973
    Event Type
    Injury
    Date Received
    July 29, 1994
    Date of Event
    February 24, 1994
    Report Date
    March 9, 1994
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THIS PT'S CHEST TUBE WAS BEING REMOVED IT FRACTURED. THE RETAINED FRAGMENT OF THE CHEST TUBE WAS SURGICALLY REMOVED UNDER GENERAL ANESTHESIA. THE CHEST TUBE HAD BEEN IN PLACE APPROX 3 WEEKS BEFORE IT BROKE ON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM TRAUM ANGLE SILICONE CATHETER Implant CHEST TUBE KDQ AXIOM MEDICAL, INC. 36 FRENCH

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention