BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICURE PRO 2

    MDR report key: 6025424 · Received October 11, 2016

    Report

    Report Number
    MW5065354
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    June 21, 2016
    Report Date
    October 11, 2016
    Manufacturer
    ATRICURE INC.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ATRICURE CLIP DID NOT OPEN. ITEM WAS TAKEN BY THE ATRICURE INC., SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670572 ATRICURE PRO 2 CLIP IMPLANTABLE FZP ATRICURE INC. 65272

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR