BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    LATERA 20MM, FINAL KIT

    MDR report key: 19113321 · Received April 15, 2024

    Report

    Report Number
    3006345872-2024-00004
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 31, 2024
    Report Date
    July 27, 2024
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    NHB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE: 1 PREVIOUSLY REPORTED EVENT IS INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION.

    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 INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A PATIENT DEVICE INTERACTION PROBLEM. 1 EVENT HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A PATIENT DEVICE INTERACTION PROBLEM. 1. EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333474 LATERA 20MM, FINAL KIT POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ENTELLUS MEDICAL, INC. VMSR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown