BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERA ABSORBABLE NASAL

    MDR report key: 10525525 · Received September 11, 2020

    Report

    Report Number
    3006345872-2020-00005
    Event Type
    Injury
    Date Received
    September 11, 2020
    Date of Event
    March 1, 2019
    Report Date
    September 11, 2020
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    NHB
    UDI-DI
    00857037006082
    PMA / PMN Number
    K161191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DISSOLVES.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED A CYST IN THEIR LEFT NASAL SIDEWALL. THE LATERA WAS IMPLANTED 1.5 YEARS AGO. EVENTUALLY THE PHYSICIAN TOOK THE PATIENT INTO SURGERY FOR EXTERNAL REMOVAL. THE PATIENT HAD GOOD RESULTS REGARDING THEIR AIRWAY, AND COSMETICALLY, IT HEALED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988743 LATERA ABSORBABLE NASAL EAR, NOSE, THROAT SYNTHETIC POLYMER MATERIAL NHB ENTELLUS MEDICAL, INC. LATANI24 UNKNOWN 00857037006082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other