BEUDAMED
    FDA Adverse Event Other Summary report: N

    COVIDIEN

    MDR report key: 1076229 · Received June 17, 2008

    Report

    Report Number
    1076229
    Event Type
    Other
    Date Received
    June 17, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 23, 2008
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED PARTIAL THICKNESS BURNS DURING SURGERY. BURNS APPEARED TO BE CAUSED BY THE COATED ELECTRODE. THE SURGEON EXCISED THE BURNED AREA DURING PROCEDURE. THE ELECTRO SURGICAL UNIT WAS ASSESSED BY BIOMEDICAL ENGINEERS AND FOUND TO BE WORKING FINE. NO FURTHER TREATMENT REQUIRED. APPROXIMATE SIZE OF BURNS WAS 1 CM X 6 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN COATED ELECTRO BLADE 2.75 INCHES GEI COVIDIEN E1455NSB 136410

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other