BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT

    MDR report key: 49905 · Received November 13, 1996

    Report

    Report Number
    2522007-1996-00005
    Event Type
    Injury
    Date Received
    November 13, 1996
    Date of Event
    July 29, 1996
    Report Date
    October 17, 1996
    Manufacturer
    COOK PACEMAKER CORP.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INFO RECEIVED FROM THE DISTRIBUTOR STATED: "THY HAD TO REMOVE THE PORT, BECAUSE THE CATHETER WAS BROKEN 12 CM FAR FROM THE PROXIMAL PART. PLACE OF BREAKAGE UNDER THE COLLARBONE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL-PORT Implant VASCULAR ACCESS SYSTEM LJT COOK PACEMAKER CORP. 7110V 030493-3

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention