BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM-SILICONE CATHETER

    MDR report key: 35137 · Received July 2, 1996

    Report

    Report Number
    35137
    Event Type
    Injury
    Date Received
    July 2, 1996
    Date of Event
    January 27, 1996
    Report Date
    January 30, 1996
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF CHEST TUBES ON 1/24 & 1/27 RESULTED IN COMPLETE BREAK OF TUBES REQUIRING SURGICAL REMOVAL OF RETAINED PIECES. NO ADVERSE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM-SILICONE CATHETER Implant CHEST TUBE 24 FRENCH KDQ AXIOM MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention