BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ABSCESSION GENERAL DRAINAGE CATHETER

    MDR report key: 1010485 · Received February 5, 2008

    Report

    Report Number
    1010485
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    December 19, 2007
    Report Date
    February 5, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN DOING PROCEDURE, NOTICED PIGTAIL END OF CATHETER WAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ABSCESSION GENERAL DRAINAGE CATHETER CATHETER, DRAINAGE GBX ANGIODYNAMICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR