BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 23488209 · Received November 6, 2025

    Report

    Report Number
    3011625895-2025-00015
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 7, 2025
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    00888479300238
    PMA / PMN Number
    K221907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT UNCOMPLICATED TREATMENT ON BOTH NOSTRILS WITH THE RHINAER STYLUS. APPROXIMATELY TWO WEEKS POST-PROCEDURE, THE PATIENT PRESENTED WITH SEVERE EPISTAXIS IN THE RIGHT NOSTRIL. THE PATIENT RECEIVED NASAL PACKING AND THE FOLLOWING DAY A RIGHT SPHENOPALATINE ARTERY LIGATION WAS PERFORMED. AT THE TIME OF THE LIGATION, THERE WAS NO ACTIVE BLEEDING. THE PATIENT WAS SEEN APPROXIMATELY ONE WEEK AFTER THE SURGERY AND NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648972 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 00888479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other