BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPANDABLE LEMAITRE VALVULOTOME

    MDR report key: 1392425 · Received May 8, 2009

    Report

    Report Number
    1392425
    Event Type
    Malfunction
    Date Received
    May 8, 2009
    Date of Event
    April 29, 2009
    Report Date
    May 8, 2009
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE VALVULOTOME WOULD NOT OPEN AND CLOSE VERY EASILY. APPEARS TO BE A DEFECT ON THE PROXIMAL SHEATH NEAR THE HAND PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPANDABLE LEMAITRE VALVULOTOME SAPHENOUS VEIN VALVE CUTTER MGZ LEMAITRE VASCULAR, INC. * ELV3 1246V

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR