BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATERA 24MM KIT 1 PACK OUS

    MDR report key: 19992461 · Received August 15, 2024

    Report

    Report Number
    3006345872-2024-00013
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 15, 2024
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    NHB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LATERA IMPLANT WAS PLACED IN (B)(6) OF 2023 AND IN (B)(6) 2024 THE IMPLANT HAS MIGRATED AND FRACTURED. THERE HAS BEEN NO REPORTED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095457 LATERA 24MM KIT 1 PACK OUS POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ENTELLUS MEDICAL, INC. 239820

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female