BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINUS MERCY OKC

    MDR report key: 23110973 · Received September 22, 2025

    Report

    Report Number
    1423395-2025-00138
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 22, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OGR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2025 "WHEN THE SURGEON WAS MAKING AN INCISION IN THE CONCHA BULLOSE THE 15 BLADE BROKE IN HALF AND FELL DOWN INTO THE SINUS CAVITY". PER THE FACILITY "THE SURGEON WAS ABLE TO RETRIEVE THE BLADE WITH THE SCOPE AND SUCTION AND BOTH PIECES WERE COMPARED TO ENSURE THE ENTIRE BLADE WAS REMOVED". PER THE FACILITY THE PROCEDURE WAS ABLE TO BE COMPLETED, HOWEVER, THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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

    ACCORDING TO THE FACILITY ON (B)(6) 2025 "WHEN THE SURGEON WAS MAKING AN INCISION IN THE CONCHA BULLOSE THE 15 BLADE BROKE IN HALF AND FELL DOWN INTO THE SINUS CAVITY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026660 SINUS MERCY OKC OGR MEDLINE INDUSTRIES, LP 25EMD952

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention