BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI ACCU-TEMP

    MDR report key: 20308968 · Received September 26, 2024

    Report

    Report Number
    20308968
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    July 8, 2024
    Report Date
    July 10, 2024
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HQP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BOVIE PEN WAS USED DURING PATIENT CARE AND A SPARK IGNITED. PATIENT PULLED HIS FINGER AWAY IMMEDIATELY AND THE CHUCKS PAD BURNED SOME. NO OBVIOUS SIGNS OF INJURY WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264447 BVI ACCU-TEMP UNIT, CAUTERY, THERMAL, BATTERY-POWERED HQP BEAVER-VISITEC INTERNATIONAL, INC. 8442000 6050719

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Other