BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    LATERA 24MM, FINAL KIT

    MDR report key: 24954033 · Received April 22, 2026

    Report

    Report Number
    3015967359-2026-99254
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Report Date
    April 22, 2026
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    NHB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION. EVALUATION FINDINGS (RESULTS/COMPONENTS): 1 DEVICE: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION: 1 DEVICE: DEVICE IMPLANTED. ADDITIONAL INFORMATION: 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: PATIENT DEVICE INTERACTION PROBLEM. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602418 LATERA 24MM, FINAL KIT POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ENTELLUS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown