BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUCLEAR

    MDR report key: 3792390 · Received January 24, 2014

    Report

    Report Number
    3792390
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 24, 2014
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE BEGAN TO LEAK WHEN INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57252 VASCUCLEAR ELECTROSURGICAL, CUTTING & COAGULATION GEI SORIN GROUP USA, INC. VC17 1330800018

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR