BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA

    MDR report key: 510150 · Received February 6, 2004

    Report

    Report Number
    510150
    Event Type
    Other
    Date Received
    February 6, 2004
    Date of Event
    October 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    THORATEC LAB CORP
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A GRAFT WAS SURGICALLY PLACED IN THE RIGHT LEG OF A PT. A HEMATOMA DEVELOPED AT THE GRAFT SITE. THE GRAFT WAS OCCLUDED. THE PHYSICIAN STATES BANDS INSIDE OF THE GRAFT CAUSED THE OCCLUSION. THE GRAFT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GRAFT DSY THORATEC LAB CORP * 19961.2

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other NO