BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM TRAUM THORACIC SILICONE CATHETER

    MDR report key: 1961028 · Received January 10, 2011

    Report

    Report Number
    MW5018968
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 15, 2010
    Report Date
    January 10, 2011
    Manufacturer
    AXIOM MEDICAL INC.
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REMOVAL OF THORACIC SILICONE CATHETER USED AS A CHEST DRAINAGE TUBE, CATHETER BROKE LEAVING A 6" SECTION RETAINED. ADDITIONAL SURGERY REQUIRED TO REMOVE RETAINED SECTION OF CATHETER. REMOVAL SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM TRAUM THORACIC SILICONE CATHETER AXIOM TRAUM THORACIC SILICONE CATHETER GBX AXIOM MEDICAL INC. 32 FRENCH 6 EYES 1002938

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization