BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVIE SMOKE EVACUATION PENCIL

    MDR report key: 19777707 · Received July 17, 2024

    Report

    Report Number
    MW5157389
    Event Type
    Injury
    Date Received
    July 17, 2024
    Report Date
    July 16, 2024
    Manufacturer
    BOVIE MEDICAL CORP./SYMMETRY SURGICAL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE UNIT NEEDS TO BE EVALUATED, DEVICE WAS SEQUESTERED WITH ACCESSORIES. PATIENT WAS REPORTED TO HAVE A BURN ON THE RIGHT UPPER ARM FROM THE UNIT. HYDROGEL AND FOAM DRESSING WAS DONE TO TREAT THE BURN SITE. A PHOTO WAS ATTACHED SHOWING THE BURN ON THE PATIENT'S SKIN. A NON-(B)(6) PENCIL WAS USED TOGETHER WITH THE DEVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978605 BOVIE SMOKE EVACUATION PENCIL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOVIE MEDICAL CORP./SYMMETRY SURGICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown