BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMPORT IMPLANTABLE VASCULAR ACCESS SYSTEM

    MDR report key: 113999 · Received June 6, 1997

    Report

    Report Number
    1222629-1997-90001
    Date Received
    June 6, 1997
    Date of Event
    April 30, 1997
    Manufacturer
    GERARD MEDICAL, INC.
    Product Code
    LJT
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CO RECEIVED, ON MAY 19, 1997, A MEDWATCH REPORT INFORMING THAT THE PREVIOUSLY REFERENCED DEVICE HAD, ON APRIL 30, 1997, BEEN EXPLANTED FROM THE PT. THIS WAS NECESSARY BECAUSE THE LAST 5" OF THE DISTAL END OF THE CATHETER HAD BEEN COMPLETELY TORN FROM THE DEVICE. THE DEVICE HAD BEEN IMPLANTED ON AUGUST 22, 1996. THE EXPLANTED DEVICE WAS SENT TO GERARD FOR ANALYSIS. CO FOUND THAT ONE END OF THE CATHETER WAS NOTICEABLY COMPRESSED OR FISH MOUTHED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMPORT IMPLANTABLE VASCULAR ACCESS SYSTEM VASCULAR ACCESS SYSTEM LJT GERARD MEDICAL, INC. * 356034

    Patients

    Seq Age Sex Outcome Treatment
    1 *