BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZE-SIT VALVULOTOME

    MDR report key: 20211877 · Received September 13, 2024

    Report

    Report Number
    20211877
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    June 17, 2024
    Report Date
    June 19, 2024
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    "DAMAGED" LE MAITRE EZE-SIT VALVULOTOME USED IN CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113805 EZE-SIT VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. 94CM TRU183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown