BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFIX II SYSTEM, US

    MDR report key: 11728009 · Received April 26, 2021

    Report

    Report Number
    3006345872-2021-00004
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    April 3, 2021
    Report Date
    April 26, 2021
    Manufacturer
    ARRINEX, INC.
    Product Code
    GEH
    UDI-DI
    00868438000234
    PMA / PMN Number
    K190536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    TWO WEEKS POST CLARIFIX PROCEDURE ((B)(6) 2021), THE PATIENT PRESENTED WITH A SEVERE NOSE BLEED ((B)(6) 2021). THE PATIENT WAS PACKED WITH RHINOROCKET AND ADMITTED TO THE HOSPITAL FOR OBSERVATION. THE PATIENT HAD A UNILATERAL BLEED ON THE LEFT SIDE, WAS ON ELIQUIS AND A PRIOR HISTORY OF POLYPS AND SINUS SURGERY. THE NEXT DAY ((B)(6) 2021), THE DOCTOR TOOK THE PATIENT TO THE OR TO CAUTERIZE THE SPHENOPALATINE ARTERY BRANCH ON THE LEFT SIDE. NO FURTHER BLEEDING HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619640 CLARIFIX II SYSTEM, US CRYOSURGICAL UNIT AND ACCESSORIES GEH ARRINEX, INC. CFX-1000 UNKNOWN 00868438000234

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other