BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A-TRAUM 28 FRENCH THORACIC SILICONE CATHETER

    MDR report key: 3362426 · Received September 17, 2013

    Report

    Report Number
    MW5031917
    Event Type
    Injury
    Date Received
    September 17, 2013
    Date of Event
    July 15, 2013
    Report Date
    September 16, 2013
    Manufacturer
    AXIOM MEDICAL, INC
    Product Code
    GBS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD THORACOTOMY PROCEDURE ON (B)(6) 2013. POST-OPERATIVELY, CHEST TUBE WAS PULLED, WITHOUT NOTICE THE ENTIRE TUBE WAS NOT INTACT. ON (B)(6) 2013, ORIGINAL SURGEON REPORTED RETAINED CHEST TUBE. ON (B)(6) 2013, APPROX 7" PIECE OF TUBE WAS SURGICALLY REMOVED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466895 A-TRAUM 28 FRENCH THORACIC SILICONE CATHETER THORACIC CATHETER GBS AXIOM MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization