BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CLARIFIX

    MDR report key: 22647413 · Received July 29, 2025

    Report

    Report Number
    3006345872-2025-99001
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Report Date
    January 29, 2026
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    GEH
    UDI-DI
    00850002250404
    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. MFR REPORT#: 3006345872-2025-99001. SUPPLEMENTAL RATIONALE: CORRECTED DATA: B5, H6, H11. 15 PREVIOUSLY REPORTED EVENTS WERE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. 7 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 7 DEVICES WERE RECEIVED. EVALUATION FINDINGS (RESULTS/COMPONENTS): 1 DEVICE: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. 7 DEVICES: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. 1 DEVICE: MANUFACTURING PROCESS PROBLEM IDENTIFIED, FATIGUE PROBLEM / BALLOON, MEMBRANE, ADHESIVE. 6 DEVICES: MANUFACTURING PROCESS PROBLEM IDENTIFIED / MEMBRANE, ADHESIVE. PRODUCT DISPOSITION: 7 DEVICES: SCRAPPED BY CUSTOMER. 7 DEVICES: SCRAPPED BY STRYKER. 1 DEVICE: PRODUCT DISPOSITION IS NOT YET DETERMINED.

    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: 18 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 8 DEVICES WERE RECEIVED. 10 DEVICES HAD INVESTIGATION TYPES THAT HAVE NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 18 DEVICES WERE 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 # 3006345872-2025-99001. SUPPLEMENTAL RATIONALE. CORRECTED DATA: B5, H6, H11. 15 PREVIOUSLY REPORTED EVENTS WERE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS. 8 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 7 DEVICES WERE RECEIVED. EVALUATION FINDINGS (RESULTS/COMPONENTS). 8 DEVICES: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. 1 DEVICE: MANUFACTURING PROCESS PROBLEM IDENTIFIED, FATIGUE PROBLEM / BALLOON, MEMBRANE, ADHESIVE. 6 DEVICES: MANUFACTURING PROCESS PROBLEM IDENTIFIED / MEMBRANE, ADHESIVE. PRODUCT DISPOSITION. 8 DEVICES: SCRAPPED BY CUSTOMER. 7 DEVICES: SCRAPPED BY STRYKER.

    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 APRIL 1 ¿ JUNE 30 2025. THIS REPORT SUMMARIZES 15 EVENTS FOR THE FAILURE: FREE OR UNRESTRICTED FLOW. 15 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 18 EVENTS FOR THE FAILURE: FREE OR UNRESTRICTED FLOW. 17 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087744 CLARIFIX UNIT, CRYOSURGICAL, ACCESSORIES GEH ENTELLUS MEDICAL, INC. 00850002250404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown