BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFIX II SYSTEM, US

    MDR report key: 11049854 · Received December 21, 2020

    Report

    Report Number
    3006345872-2020-00010
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    October 22, 2020
    Report Date
    December 21, 2020
    Manufacturer
    ARRINEX, INC.
    Product Code
    GEH
    PMA / PMN Number
    K190356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A PATIENT ENROLLED IN A (B)(6) POST MARKET STUDY HAD AN UNEVENTFUL PROCEDURE (B)(6) 2020. TWENTY DAYS POST PROCEDURE ((B)(6) 2020), SHE HAVE SEVERE NASAL BLEEDING AND WENT TO THE HOSPITAL. AFTER ATTEMPTS AT NASAL PACKING, SHE HAD HER LEFT SIDE EMBOLIZED AND WAS ADMITTED TO THE HOSPITAL OVERNIGHT FOR OBSERVATION. SHE WAS RELEASED THE NEXT DAY ((B)(6) 2020) WITHOUT FURTHER ISSUE. NO FURTHER BLEEDING HAS BEEN NOTED AND THE PATIENT IS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510837 CLARIFIX II SYSTEM, US CRYOSURGICAL UNIT AND ACCESSORIES GEH ARRINEX, INC. 20013101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other