BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 16417869 · Received February 22, 2023

    Report

    Report Number
    1417592-2023-00069
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 22, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OJG
    UDI-DI
    10195327324704
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 DURING A "MULTI-LEVEL LUMBAR LAMI CASE" WHEN USING A NEURO CUSTOM PACK THE INSULATION BOVIE TIP FELL OFF AND "WAS RECOVERED IN THE SURGICAL WOUND INTACT". THE CUSTOMER REPORTED THAT AFTER THE INCIDENT ANOTHER STERILE INSULATED BOVIE TIP WAS OPENED AND USED. THE CUSTOMER REPORTED THERE WAS NO MEDICAL INTERVENTION OR SERIOUS INJURY RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SAMPLE REQUESTED TO BE RETURNED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. 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.

    Additional Manufacturer Narrative · 0

    REPORT WAS FILED UNDER THE INCORRECT MANUFACTURING ID 1417592-2023-00069. AN ADDITIONAL MDR WILL BE FILED UNDER THE CORRECT MANUFACTURING ID 1423395-2023-00007.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 DURING A "MULTI-LEVEL LUMBAR LAMI CASE" WHEN USING A NEURO CUSTOM PACK THE INSULATION BOVIE TIP FELL OFF AND "WAS RECOVERED IN THE SURGICAL WOUND INTACT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611481 MEDLINE INDUSTRIES, INC. NEURO CDS OJG MEDLINE INDUSTRIES, LP CDS985246K 22JMC941 10195327324704

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other