BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELMED INCORPORATED

    MDR report key: 601296 · Received May 6, 2005

    Report

    Report Number
    MW1035411
    Event Type
    Malfunction
    Date Received
    May 6, 2005
    Date of Event
    April 6, 2005
    Report Date
    April 29, 2005
    Manufacturer
    ELMED, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN SURGERY UNDERGOING RADICAL PROSTATECTOMY. WHEN THE PHYSICIAN ACTIVATED THE 7" CAUTERY, THE CONTACTS ARCED TO THE PT'S SKIN. PT SUSTAINED A SMALL BURN, BACITRACIN APPLIED. CAUTERY WAS REMOVED FROM USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELMED INCORPORATED CAUTERY DEVICE GEI ELMED, INC. * 5320M

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other