BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROCAUTERY DEVICE REUSABLE GROUNDING PAD

    MDR report key: 20938089 · Received December 16, 2024

    Report

    Report Number
    20938089
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    August 16, 2024
    Report Date
    October 23, 2024
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGEON WAS PERFORMING A C-SECTION AND WAS BURNED ON HIS FINGER BY THE BOVIE. THE GROUNDING PAD WAS A REUSABLE PAD UNDER THE PATIENT. AN ADHESIVE GROUNDING PAD WAS THEN PLACED TO THE PATIENT'S LEG WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375009 ELECTROCAUTERY DEVICE REUSABLE GROUNDING PAD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEGADYNE MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other