BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN_ENTELLUSSPIROX_PRODUCT

    MDR report key: 11679170 · Received April 16, 2021

    Report

    Report Number
    3006345872-2021-00002
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    July 1, 2020
    Report Date
    August 10, 2021
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    NHB
    PMA / PMN Number
    K192661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED JUNE 25, 2021 REPORTED THE PATIENT HAS AN ODD TINGLING SENSATION ALONG WITH PERSISTENT VALVULAR COLLAPSE. THE PATIENT IS CONSIDERING ANOTHER SURGERY BUT WILL WAIT 12-18 MONTHS TO GIVE THE LATERA IMPLANT TIME TO BE ABSORBED. H3 OTHER TEXT: DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    A 64-YEAR OLD MALE PATIENT PRESENTED WITH IMPLANT REJECTION ON THE LEFT SIDE OF HIS NOSE APPROXIMATELY 2 MONTHS AFTER IMPLANT. THE IMPLANT SITE WAS RAISED AND INFLAMED AT THE FOR TIP. THE PATIENT WAS TREATED WITH AFRIN, SALINE RINSE AND A STEROID INJECTION. THE IMPLANT WAS EVENTUALLY REMOVED. IT WAS NOT RETURNED TO ENTELLUS FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED JUNE 25, 2021 REPORTED THE PATIENT HAS AN ODD TINGLING SENSATION ALONG WITH PERSISTENT VALVULAR COLLAPSE. THE PATIENT IS CONSIDERING ANOTHER SURGERY BUT WILL WAIT 12-18 MONTHS TO GIVE THE LATERA IMPLANT TIME TO BE ABSORBED.

    Additional Manufacturer Narrative · 1

    A SMALL PORTION OF THE DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT PRESENTED WITH IMPLANT REJECTION ON THE LEFT SIDE OF HIS NOSE APPROXIMATELY 2 MONTHS AFTER IMPLANT. THE IMPLANT SITE WAS RAISED AND INFLAMED AT THE FOR TIP. THE PATIENT WAS TREATED WITH AFRIN, SALINE RINSE AND A STEROID INJECTION. THE IMPLANT WAS EVENTUALLY REMOVED. IT WAS NOT RETURNED TO ENTELLUS FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575383 UNKNOWN_ENTELLUSSPIROX_PRODUCT NHB, LATERA ABSORBABLE NASAL NHB ENTELLUS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention