BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGADYNE

    MDR report key: 11759685 · Received May 3, 2021

    Report

    Report Number
    11759685
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 12, 2021
    Report Date
    April 22, 2021
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559100141
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE, IT WAS NOTED THAT THE PATIENT'S SKIN HAD SEVERAL BURN MARKS AROUND THE INCISION SITE. DOCTOR INSPECTED THE BOVIE TIP, WHICH HAD A BREAK IN THE INSULATION. NO ALARM SOUND WAS NOTED OR HEARD FROM THE VALLEY LAB UNIT. THE BOVIE TIP WAS ISOLATED REMOVED AND REPLACED. THE INCIDENT WAS REPORTED TO THE CHARGE NURSE AND THE BOVIE TIP WAS HANDED TO HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660150 MEGADYNE ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI MEGADYNE MEDICAL PRODUCTS, INC. 0014 205224 10614559100141

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA Other