BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMCATH DUAL LUMEN CATHETER

    MDR report key: 1726596 · Received June 10, 2010

    Report

    Report Number
    1726596
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 10, 2010
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    PERMCATH CAUSED PINCHING. PT HAS SUPERIOR VENA CAVA (SVC) STENOSIS AND VESSEL IS ANGIOPLASTIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMCATH DUAL LUMEN CATHETER DUAL LUMEN CATHETER LFJ MEDICAL COMPONENTS, INC. * MBYV070

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR