BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMPORT

    MDR report key: 31831 · Received April 8, 1996

    Report

    Report Number
    MW1008819
    Event Type
    Injury
    Date Received
    April 8, 1996
    Date of Event
    March 22, 1996
    Report Date
    March 29, 1996
    Manufacturer
    GERARD MEDICAL ENTERPRISES, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED NECK AND ARM PAIN ABOVE CATHETER SITE. PT CAME TO HOSP FOR DYE STUDY. UNABLE TO FLUSH. PT COMPLAINED OF PAIN AND NECK NOW SWOLLEN. DYE STUDY SHOWED A PIECE OF CATHETER FREE-FLOATING IN RIGHT ATRIUM. PT UNDERWENT PROCEDURE VIA GROIN AREA TO RETRIEVE THE PIECE. PT DISCHARGED. NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMPORT Implant IMPLANTABLE VASCULAR DEVICE LJT GERARD MEDICAL ENTERPRISES, INC. 270005

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R