BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD MEDICAL CONCEPTS REPROCESSED ETHICON

    MDR report key: 705270 · Received April 10, 2006

    Report

    Report Number
    MW1038458
    Event Type
    Malfunction
    Date Received
    April 10, 2006
    Date of Event
    April 7, 2006
    Report Date
    April 10, 2006
    Manufacturer
    VANGUARD MEDICAL CONCEPTS, INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN PLACING THE FILSHIE CLIP APPLIER THROUGH #7-8 TROCAR 1MM SILASTIC GASKET WAS PUSHED THROUGH INTO THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD MEDICAL CONCEPTS REPROCESSED ETHICON 7/8 DILATING TIP TROCAR STABILITY SLEEVE. 100MM GCJ VANGUARD MEDICAL CONCEPTS, INC * 94289

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other