BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERA 24MM, FINAL KIT

    MDR report key: 10951119 · Received December 5, 2020

    Report

    Report Number
    3006345872-2020-00009
    Event Type
    Injury
    Date Received
    December 5, 2020
    Date of Event
    November 10, 2020
    Report Date
    December 4, 2020
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    NHB
    PMA / PMN Number
    K192661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND HAS NOT BEEN REMOVED. DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    TWO WEEKS AFTER IMPLANT, THE PATIENT REPORTED THAT ONE SIDE WAS SHOWING TWO RAISED RED SPOTS (BY FORKS). THE PATIENT WAS PRESCRIBED ANTIBIOTICS DUE TO CONCERN OF AN INFECTION. THE ISSUE RESOLVED BUT A WEEK LATER HAS RETURNED. THE ROOT CAUSE OF THE REPORTED PROBLEM IS UNKNOWN AND STRYKER ENT IS NOT AWARE OF ANY ADDITIONAL ANTIBIOTIC THERAPY OR THE IMPLANT STATUS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415721 LATERA 24MM, FINAL KIT NHB, LATERA ABSORBABLE NASAL NHB ENTELLUS MEDICAL, INC. LATANI24 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other