BEUDAMED
    FDA Adverse Event Death Summary report: N

    REDFIELD

    MDR report key: 674083 · Received February 10, 2006

    Report

    Report Number
    1216677-2006-00003
    Event Type
    Death
    Date Received
    February 10, 2006
    Date of Event
    November 23, 2005
    Report Date
    February 3, 2006
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WAS TREATED FOR HEMORROIDS USING AN INFRARED COAGULATOR. PT WAS FOUND PASSED OUT AND BLEEDING AT HOME. PT WAS BROUGHT TO THE HOSPITAL VIA AMBULANCE. AFTER THE INITIAL EXAM, THE PT HAD SEVERAL DEFECTS OR "HOLES" IN THE RECTAL MUCOSA OF THE RIGHT POSTERIOR PILE. PT WAS TAKEN INTO SURGERY WHERE THE "HOLES" WERE SUTURED IN ORDER TO STOP THE BLEEDING. THE PT EXPIRED THE FOLLOWING MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDFIELD INFRARED COAGULATOR GEI COOPERSURGICAL, INC. IRC-HS1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death