BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLYING LEAD BIPOLAR FORCEPS CORD

    MDR report key: 11308718 · Received February 10, 2021

    Report

    Report Number
    11308718
    Event Type
    Injury
    Date Received
    February 10, 2021
    Date of Event
    December 30, 2020
    Report Date
    December 30, 2020
    Manufacturer
    NEW DEANTRONICS TAIWAN LTD
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER REMOVING MOUTH GAG FOLLOWING THE EXCISION OF UVULAR LESION UNDER GENERAL ANESTHESIA, SMALL ESCHAR AT COMER OF PATIENT'S MOUTH WAS NOTED. FLYING LEAD BIPOLAR CORD HAD TOUCHED THAT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207993 FLYING LEAD BIPOLAR FORCEPS CORD ELECTROSURGICAL APPARATUS GEI NEW DEANTRONICS TAIWAN LTD 4000J 2003384

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other