BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM

    MDR report key: 649093 · Received November 18, 2005

    Report

    Report Number
    649093
    Event Type
    Malfunction
    Date Received
    November 18, 2005
    Date of Event
    October 18, 2005
    Report Date
    November 10, 2005
    Manufacturer
    AXIOM MEDICAL INC
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT RADICAL RETROPUBIC PROSTATECTOMY. ON POST OPERATIVE DAY #1, WHEN THE PATIENT'S JACKSON-PRATT DRAIN WAS ATTEMPTED TO BE REMOVED A PORTION OF THE DRAIN BROKE. THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY FOR SURGICAL REMOVAL OF THE REMAINDER OF THE JACKSON-PRATT DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM OPERATIVE DRAIN SECTION GCY AXIOM MEDICAL INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *