BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CLARIFIX CANISTER

    MDR report key: 23399932 · Received October 28, 2025

    Report

    Report Number
    3015967359-2025-99528
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Report Date
    January 27, 2026
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    GEH
    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. REPORTED EVENTS: 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS): 1 DEVICE: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION: 1 DEVICE: PRODUCT DISPOSITION IS NOT YET DETERMINED. ADDITIONAL INFORMATION: 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99528. SUPPLEMENTAL RATIONALE CORRECTED DATA: B5, H6, H11. 1 PREVIOUSLY REPORTED EVENT WAS INCLUDED IN THIS FOLLOW-UP RECORD. 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: PRODUCT NOT RECEIVED.

    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 JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FREE OR UNRESTRICTED FLOW. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    NO CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2798444 CLARIFIX CANISTER UNIT, CRYOSURGICAL, ACCESSORIES GEH ENTELLUS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown