BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM 7FRENCH CATHETER

    MDR report key: 366047 · Received December 11, 2001

    Report

    Report Number
    366047
    Event Type
    Injury
    Date Received
    December 11, 2001
    Date of Event
    August 25, 2001
    Report Date
    October 22, 2001
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    GCY
    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

    DURING REMOVAL OF DRAIN FROM PT'S SCALP, TUBING BROKE. END OF TUBING NOTED TO BE UNEVEN. PT WENT TO OR FOR REMOVAL OF RETAINED PIECE OF TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55813 AXIOM 7FRENCH CATHETER WOUND DRAINAGE DEVICE GCY AXIOM MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 MO Required Intervention DAVOL BULB SUCTION (2001 TO 2001).