BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERA 20MM, FINAL KIT

    MDR report key: 23301418 · Received October 15, 2025

    Report

    Report Number
    3006345872-2025-00012
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 2, 2025
    Report Date
    February 5, 2026
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    NHB
    UDI-DI
    00857037006037
    PMA / PMN Number
    K192661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT SUBMITTED TO DOCUMENT ADDITIONAL SURGERY DOCUMENTED IN B5.

    Additional Manufacturer Narrative · 0

    FOR H6 CLINICAL SIGNS CODE GRID, CURRENTLY A RELEVANT CODE IS NOT AVAILABLE IN OUR SYSTEM TO ACCURATELY CAPTURE THE IMPLANT MIGRATING HENCE THE APPROPRIATE CODE / TERM NOT APPLICABLE WAS CHOSEN.

    Description of Event or Problem · 0

    THE PATIENT WAS REIMPLANTED ON THE RIGHT NASAL ANATOMY AND NO FURTHER ISSUES HAVE BEEN NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WITH BILATERAL LATERA NASAL IMPLANTS EXPERIENCED EXPULSION OF THE RIGHT IMPLANT WITHIN THE FIRST WEEK OF IMPLANT PLACEMENT. THE SURGEON HAS REPORTED THE PATIENT PERFORMED POST PROCEDURE MANIPULATION OF THE NOSE AND PATIENT WORE SPECTACLES. MEDICAL INTERVENTION WAS PERFORMED AND THE RIGHT NASAL IMPLANT WAS EXPLANTED FROM THE NASAL CAVITY. THE SURGEON HAS PLANNED TO RE-IMPLANT LATERA ON THE PATIENT AFTER THE EXPLANTATION SITE HAS BEEN HEALED. ADDITIONAL INFORMATION IS CURRENTLY BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2537374 LATERA 20MM, FINAL KIT POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ENTELLUS MEDICAL, INC. 25120063 00857037006037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention