BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFIX DEVICE, FG

    MDR report key: 10391136 · Received August 11, 2020

    Report

    Report Number
    3006345872-2020-00004
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    June 25, 2020
    Report Date
    August 11, 2020
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    GEH
    UDI-DI
    00868438000234
    PMA / PMN Number
    K190356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A UNEVENTFUL BILATERAL CLARIFIX PROCEDURE ON (B)(6) 2020. PATIENT BEGAN TO HAVE EPISODIC POSTERIOR NOSE BLEEDS ON (B)(6) 2020. SEEN AT CLINIC ON (B)(6) 2020. ENDOSCOPY SHOWED NO ACTIVE BLEEDING, NORMAL TISSUE CHANGES RELATED TO CRYOTHERAPY. SEEN BY LOCAL ED ON (B)(6) 2020 AND ON (B)(6) 2020 FOR PACKING. PATIENT WENT TO ED THAT NIGHT WITH MORE POSTERIOR BLEEDING. TRANSFERRED TO ANOTHER MEDICAL CENTER AND LEFT SIDE PACKED. ON (B)(6) 2020 VISITED THE OPERATING ROOM. WAS NOTED TO HAVE BILATERAL BRISK BLEEDING FROM THE POSTERIOR END OF THE TREATMENT SITE BILATERALLY. BLEEDING WAS CONTROLLED WITH ENDOSCOPIC MONOPOLAR CAUTERY BILATERALLY. SHE WAS KEPT OVERNIGHT (B)(6) FOR OBSERVATION FOR ADDITIONAL BLEEDING AND WAS DISCHARGED THE AM OF (B)(6). SHE HAS RECOVERED WITHOUT SEQUELAE OR OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857588 CLARIFIX DEVICE, FG CRYOSURGICAL UNIT AND ACCESSORIES GEH ENTELLUS MEDICAL, INC. CFX-1000 UNKNOWN 00868438000234

    Patients

    Seq Age Sex Outcome Treatment
    1 70 Other