BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 10914484 · Received November 27, 2020

    Report

    Report Number
    1423395-2020-00034
    Event Type
    Malfunction
    Date Received
    November 27, 2020
    Date of Event
    November 4, 2020
    Report Date
    November 27, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OGR
    UDI-DI
    10889942890521
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EMAIL RECEIVED BY DIRECTOR OF NURSING, (B)(6) SURGICAL CENTER. REPORTER STATES, ON (B)(6) 2020 A (B)(6), MALE PATIENT WAS HAVING A TONSILLECTOMY AND ADENOIDECTOMY. REPORTER STATES, "BILATERAL BURNS CREATED TO THE CORNER OF THE MOUTH WHILE REMOVING TONSIL AND ADENOIDS." REPORTER STATES, "GENERAL ANESTHESIA WAS USED, NO ADDITIONAL ANESTHESIA REQUIRED. ANTIBIOTIC OINTMENT APPLIED." REPORTER STATES, "THE PATIENT IS DOING WELL." THE SAMPLE HAS BEEN RETURNED FOR EVALUATION. INVESTIGATION SUMMARY (11/23/2020): "THE ACCOUNT REPORTED FINDING BOVIE TIP BURNED BOTH SIDES OF THE MOUTH. THE REPORTED ISSUE OCCURRED IN ITEM DYNJ52893C (LOT 20BBT103). DUE TO THE FACT THAT WE WERE ABLE TO SEE CHARRING ON THE DEVICE WAS ARE ABLE TO CONFIRM THE ISSUE BUT WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE." DUE TO THE REPORTED NATURE OF THE INCIDENT AND IN ABUNDANCE OF CAUTION, THIS MEDWATCH IS FILED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "A DOCTOR PUT THE BOVIE TIP IN A PATIENT'S MOUTH AND BURNED BOTH SIDE OF THE MOUTH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380252 MEDLINE INDUSTRIES, INC. ENT/FESS PACK OGR MEDLINE INDUSTRIES INC. DYNJ52893C 20BBT103 10889942890521

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention