BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR

    MDR report key: 447800 · Received March 10, 2003

    Report

    Report Number
    MW1027802
    Event Type
    Malfunction
    Date Received
    March 10, 2003
    Date of Event
    January 15, 2003
    Report Date
    March 10, 2003
    Manufacturer
    VANGUARD MEDICAL CONCEPTS INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RUBBER REDUCER MATERIAL FRAGMENT FOUND UPON REMOVING TROCARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCAR SURGICAL TROCAR GCJ VANGUARD MEDICAL CONCEPTS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR