BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZE-SIT VALVULOTOME

    MDR report key: 11946481 · Received June 4, 2021

    Report

    Report Number
    MW5101727
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Report Date
    June 3, 2021
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    UDI-DI
    00840663102297
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRIED TO FLUSH THE VALVULOTOME THE CONNECTION WAS BROKEN. FREQUENT PROBLEM. NEW PRODUCT OBTAINED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833139 EZE-SIT VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. TIVK2030 TRU1073 00840663102297

    Patients

    Seq Age Sex Outcome Treatment
    1