BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1210278 · Received October 6, 2008

    Report

    Report Number
    3004904811-2008-00014
    Event Type
    Other
    Date Received
    October 6, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BARRX MEDICAL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A HISTORY OF ENDO MUCOSAL RESECTIONS (EMR) REPORTS EXPERIENCING DYSPHAGIA WITH SOLID FOOD. DILATION WAS PERFORMED BY THE PHYSICIAN. THERE WAS NO ASSOCIATED MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO360 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL INC. NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention