BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURN PK

    MDR report key: 19459083 · Received June 4, 2024

    Report

    Report Number
    1423395-2024-00423
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 4, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OJJ
    UDI-DI
    10195327443856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE BOVIE TIP SPARKED. THERE WAS NO INJURY REPORTED AND THE PROCEDURE WAS COMPLETED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. 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

    "BOVIE HAD A LARGE SPARK"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150065 BURN PK OJJ MEDLINE INDUSTRIES LP 10195327443856

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other