BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOPROFILE 6X20MM

    MDR report key: 10541645 · Received September 16, 2020

    Report

    Report Number
    3006345872-2020-00006
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    August 22, 2020
    Report Date
    December 4, 2020
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    LRC
    UDI-DI
    00857326005017
    PMA / PMN Number
    K163509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B2. THIS CORRECTION IS BEING FILED TO UPDATE OUTCOMES ATTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A CSF LEAK IMMEDIATELY FOLLOWING A MULTI-SINUS BALLOON DILATION PROCEDURE. THE PATIENT HAD SURGERY TO PATCH THE CSF LEAK, WAS HOSPITALIZED FOR 2-3 DAYS AND THEN DISCHARGED. NO FURTHER PATIENT INJURY OR COMPLICATIONS HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED BY USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A CSF LEAK IMMEDIATELY FOLLOWING A MULTI-SINUS BALLOON DILATION PROCEDURE. THE PATIENT HAD SURGERY TO PATCH THE CSF LEAK, WAS HOSPITALIZED FOR 2-3 DAYS AND THEN DISCHARGED. NO FURTHER PATIENT INJURY OR COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006583 LOPROFILE 6X20MM INSTRUMENT, ENT MANUAL SURGICAL LRC ENTELLUS MEDICAL, INC. MSB&LLF UNKNOWN 00857326005017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention