BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVIE DISPOSABLE SUCTION COAGULATOR WITH 10FT CABLE

    MDR report key: 21851221 · Received April 16, 2025

    Report

    Report Number
    MW5169160
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 11, 2025
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHILE USING THE SUCTION BOVIE THAT CAME IN THE ENT PACK DR. (B)(6) GOT A BURN FROM THE HANDLE BY THE SUCTION BELOW THE BUTTON, NOT THE TIP. SHE HAS HAD THIS HAPPEN PREVIOUSLY, BUT THOUGHT IT MAY HAVE JUST BEEN FLUKE. THE FIRST TIME ONLY BURNED HER GLOVE. THIS TIME IT BURNED THROUGH HER GLOVE AND ON HER FINGER. BOVIE # SCH12 LOT # 240306152.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134374 BOVIE DISPOSABLE SUCTION COAGULATOR WITH 10FT CABLE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SYMMETRY SURGICAL INC. SCH12 240306152

    Patients

    Seq Age Sex Outcome Treatment
    1 Male