BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_ARRINEX_PRODUCT

    MDR report key: 9869536 · Received March 23, 2020

    Report

    Report Number
    3015132143-2020-00003
    Event Type
    Injury
    Date Received
    March 23, 2020
    Date of Event
    March 10, 2020
    Report Date
    March 23, 2020
    Manufacturer
    ARRINEX, INC.
    Product Code
    GEH
    PMA / PMN Number
    162608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    CLARIFIX PATIENT EXPERIENCE NASAL BLEEDING 10 DAYS POST-TREATMENT ON RIGHT SIDE. SEVERAL ATTEMPTS WERE MADE TO PACK THE NASAL PASSAGEWAY, WHICH DID NOT RESOLVE ISSUE. ENDOSCOPIC VISUALIZATION SHOWED NECROTIC TISSUE AROUND LOWER POSTERIOR MIDDLE TURBINATE BUT COULD NOT VISUALIZE THE SPHENOPALATINE ARTERY. CAUTERIZATION WAS PERFORMED TO STOP BLEEDING. PATIENT RECOVERED WITH NO ADDITIONAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329544 UNKNOWN_ARRINEX_PRODUCT CRYOABLATION DEVICE GEH ARRINEX, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention