BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVIE

    MDR report key: 425627 · Received September 30, 2002

    Report

    Report Number
    425627
    Event Type
    Injury
    Date Received
    September 30, 2002
    Date of Event
    September 5, 2002
    Report Date
    September 13, 2002
    Manufacturer
    AARON MEDICAL INDUSTRIES
    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 IN OR FOR REMOVAL OF LESION LEFT LOWER EYELID. PROCEDURE VERY BLOODY. PT WEARING AN OXYGEN MASK WHICH HAD BEEN SHORTENED TO ALLOW SURGEON ACCESS TO THE LOWER LID. COTTON TIP APPLICATOR PLACED IN THE WOUND TO DAB THE BLOOD. CAUTERY PLACED IN THE WOUND AND A FLASH OCCURRED. THE COTTON APPLICATOR AND OXYGEN MASK BURNED RAPIDLY. PT SUSTAINED SECOND DEGREE BURNS TO UPPER LID AND LOWER NOSE AREA AS WELL AS FIRST DEGREE BURNS TO CHEEKS AND CHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE HAND HELD CAUTERY GEI AARON MEDICAL INDUSTRIES AA01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R OXYGEN.| COTTON TIPPED APPLICATOR-SOLON MFG CO AIRLIFE| ADULT OXYGEN MASK-ALLEGIANCE HEALTHCARE CORP,