BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1210280 · Received October 6, 2008

    Report

    Report Number
    3004904811-2008-00015
    Event Type
    Other
    Date Received
    October 6, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 4, 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

    IT WAS REPORTED THAT A PATIENT THAT UNDERWENT TREATMENT ON (B) (6) 2008, WAS ADMITTED DUE TO UPPER GASTROINTESTINAL BLEED. THE PHYSICIAN CLIPPED THE BLEEDING AREA. THE PATIENT WAS READMITTED WITH GASTROINTESTINAL BLEEDING AND HE HAD TRANSFUSION. THERE WERE NO SUBSEQUENT COMPLICATIONS AND THE EVENT IS DEEMED TO BE RESOLVED. THE PRODUCT PERFORMED AS INTENDED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO360 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R