BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTRUMENTATION BOVIE

    MDR report key: 36578 · Received July 10, 1996

    Report

    Report Number
    36578
    Event Type
    Injury
    Date Received
    July 10, 1996
    Date of Event
    January 3, 1996
    Report Date
    April 4, 1996
    Manufacturer
    INSTRUMENTARIUM CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT REPORTEDLY RECEIVED A LEFT NASAL BURN APPROX 1MM ROUND DURING SURGICAL PROCEDURE. THE BURN WAS ALLEGEDLY CAUSED BY THE SUCTION BOVIE. A PIN POINT HOLE WAS NOTED IN THE BOVIE INSULATION AFTER THE BURN OCCURRED. THE AREA WAS TREATED WITH BACITRACIN OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENTATION BOVIE BOVIE GEI INSTRUMENTARIUM CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention