BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Medline Industries, Inc.

    MDR report key: 14138339 · Received April 18, 2022

    Report

    Report Number
    1423395-2022-00012
    Event Type
    Injury
    Date Received
    April 18, 2022
    Date of Event
    March 23, 2022
    Report Date
    March 23, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    LRO
    UDI-DI
    10888277538931
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY DURING A PROCEDURE THE BOVIE TIP 'ARCED' AND THE PATIENT WAS BURNED AND REQUIRED STITCHES ON THEIR LIP. THE SAMPLE WAS RETURNED AND A THOROUGH EVALUATION WAS PERFORMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY DURING A PROCEDURE THE BOVIE TIP 'ARCED' AND THE PATIENT WAS BURNED AND REQUIRED STITCHES ON THEIR LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627451 Medline Industries, Inc. CHS LARGE BASIN PACK LRO MEDLINE INDUSTRIES LP DYNJCHSB10 22BDA560 10888277538931

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention