BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINOR PACK

    MDR report key: 14196660 · Received April 25, 2022

    Report

    Report Number
    1423395-2022-00015
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 31, 2022
    Report Date
    April 25, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    LRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY DURING A PROCEDURE THE 'INSULATED BOVIE TIP CAME OUT OF THE BOVIE PENCIL AND HAD TO BE FISHED OUT OF THE WOUND'. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. 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 'INSULATED BOVIE TIP CAME OUT OF THE BOVIE PENCIL AND HAD TO BE FISHED OUT OF THE WOUND'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196283 MINOR PACK LRO MEDLINE INDUSTRIES LP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention