BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERA ABSORBABLE NASAL 2 IMPLANTS GEN 1

    MDR report key: 10554253 · Received September 18, 2020

    Report

    Report Number
    3006345872-2020-00007
    Event Type
    Injury
    Date Received
    September 18, 2020
    Date of Event
    December 14, 2017
    Report Date
    September 18, 2020
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    NHB
    UDI-DI
    00857037006044
    PMA / PMN Number
    161191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DISSOLVES.

    Description of Event or Problem · 1

    THREE YEARS POST IMPLANT THE LATERA DEVICE IS PROTRUDING OUT THE SIDE OF THE PATIENT'S NOSE CAUSING PAIN AND DISFIGUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020104 LATERA ABSORBABLE NASAL 2 IMPLANTS GEN 1 EAR, NOSE AND THROAT SYNTHETIC POLYMER MATERIAL NHB ENTELLUS MEDICAL, INC. LATANI02 197638 00857037006044

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other