BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRUITT F3

    MDR report key: 2871339 · Received October 22, 2012

    Report

    Report Number
    2871339
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 27, 2012
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    CAROTID SHUNT BALLOON MALFUNCTIONED AND THE PATIENT LOST APPROXIMATELY 100 CC OF BLOOD. THE PATIENT RECOVERED IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRUITT F3 CAROTID SHUNT NIM LEMAITRE VASCULAR, INC. 2012-13 PFT2314

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR