BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE NEEDLE TIP CAUTERY

    MDR report key: 19485080 · Received June 6, 2024

    Report

    Report Number
    MW5155909
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 5, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) WAS PERFORMING A T&A (TONSILLECTOMY AND ADENOIDECTOMY) PROCEDURE USING CAUTERY. AT THE END OF THE PROCEDURE, THE PHYSICIAN NOTICED THAT THERE WAS A BURN ON THE INSIDE AND OUTSIDE OF THE PATIENT'S LIP. THE BURN WAS CAUSED FROM INSULATION FAILURE OF THE CAUTERY THAT WAS BEING USED. IT HAD BEEN RESTING ON THIS AREA DURING THE PROCEDURE AND THEY DIDN'T REALIZE IT WAS BURNING THROUGH UNTIL THE END. THE SURGICAL TEAM APPLIED OINTMENT TO THE BURNED AREA AND (B)(6) SAID IT WOULD BE 6 MONTHS BEFORE HE KNEW IF HE HAD TO DO ANY PLASTIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171920 ELECTRODE NEEDLE TIP CAUTERY ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDLINE INDUSTRIES, LP - NORTHFIELD 2023110990

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Disability