BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOVIE MEDICAL

    MDR report key: 2061354 · Received April 5, 2011

    Report

    Report Number
    3007593903-2011-00001
    Event Type
    Other
    Date Received
    April 5, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K945765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOVIE MEDICAL WAS UNABLE TO INSPECT THE DEVICE USED AS IT WAS DISCARDED AFTER THE CASE. IT WAS CONFIRMED THAT THE PATIENT HAD APPLIED HAIRSPRAY PRIOR TO THE PROCEDURE. THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH CAUTERIES INCLUDES THE FOLLOWING "WARNING: DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS OR IN OXYGEN-ENRICHED ENVIRONMENTS. FIRE COULD RESULT." THE USER FACILITY DID NOT HAVE A POLICY TO ADVISE PATIENTS TO NOT USE FLAMMABLE SPRAYS OR MATERIALS PRIOR TO A PROCEDURE. ALTHOUGH THE WARNING IS LOCATED IN MULTIPLE LABELING (COVER CAP IMPRINT, TUBE IMPRINT, AND POUCH TEXT), THESE WARNINGS ARE DIRECTED AT THE USER, NOT THE PATIENT. AT THE TIME OF THIS EVENT, THE FACILITY DID NOT HAVE A POLICY FOR ADVISING PATIENTS AGAINST USING ANY FLAMMABLE SPRAYS PRIOR TO A PROCEDURE. SINCE THIS EVENT, THE FACILITY HAS IMPLEMENTED A PATIENT NOTIFICATION PRACTICE TO ASSURE THAT THE PATIENT HAS NOT APPLIED HAIRSPRAYS, LOTIONS, OR OTHER POTENTIALLY FLAMMABLE MATERIALS PRIOR TO UNDERGOING A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    WHILE REMOVING A MOLE ON THE NECK, THE DEVICE WAS NEAR THE HAIRLINE AND THE CAUTERY TIP FLAMED UP CAUSING A BURN TO THE PATIENT. THE USER FACILITY DID NOT INDICATE THE NATURE OF THE DEGREE OF THE BURN, BUT INDICATED THAT INTERVENTION WAS NOT REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE. THE PATIENT HAS NOT RETURNED CALLS TO THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE MEDICAL BATTERY OPERATED CAUTERY DEVICE GEI BOVIE MEDICAL CORPORATION AA01

    Patients

    Seq Age Sex Outcome Treatment
    1