BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 25202294 · Received May 18, 2026

    Report

    Report Number
    3011625895-2026-00002
    Event Type
    Injury
    Date Received
    May 18, 2026
    Report Date
    May 18, 2026
    Manufacturer
    AERIN MEDICAL, INC.
    Product Code
    GEI
    UDI-DI
    00888479300306
    PMA / PMN Number
    K221907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLEEDING IS A KNOWN POTENTIAL ADVERSE EFFECT RELATED TO THE USE OF RADIOFREQUENCY ENERGY ON TISSUE IN THE NOSE. POTENTIAL ADVERSE EFFECTS ARE LISTED IN THE DEVICE LABELING.

    Description of Event or Problem · 0

    PATIENT UNDERWENT VIVAER AND RHINAER PROCEDURE. APPROXIMATELY ONE WEEK POST-PROCEDURE, THE PATIENT PRESENTED WITH BLEEDING AROUND THE NASAL SEPTUM AND TURBINATES. THOSE AREAS WERE CAUTERIZED IN THE PHYSICIAN'S OFFICE. A FEW DAYS LATER THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ADDITIONAL BLEEDING AND HAD PACKING AND WAS DISCHARGED. THE PATIENT EXPERIENCED PERSISTENT BLEEDING AND WENT TO THE OPERATING ROOM WHEREUPON AN AREA NEAR THE SPHENOPALATINE ARTERY WAS SUCTIONED, CAUTERIZED AND PACKED. THE PATIENT WAS REPORTED TO BE DOING WELL AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298028 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL, INC. FG2258 00888479300306

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other