BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 23706818 · Received December 3, 2025

    Report

    Report Number
    3011625895-2025-00016
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 3, 2025
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    00888479300238
    PMA / PMN Number
    K221907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT UNCOMPLICATED TREATMENT WITH THE RHINAER STYLUS. APPROXIMATELY TWO WEEKS POST-PROCEDURE, THE PATIENT PRESENTED WITH SEVERE EPISTAXIS. THE NOSTRIL WAS PACKED BUT PHYSICIAN COULD NOT CONTROL THE EPISTAXIS. THE PATIENT RECEIVED MULTIPLE UNITS OF BLOOD VIA TRANSFUSION AND ULTIMATELY HAD TO BE INTUBATED AND PLACED ON A VENTILATOR DUE TO CONCERN WITH ASPIRATION. THE PATIENT UNDERWENT SUCCESSFUL SPA LIGATION SURGERY THE NEXT DAY AND IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2838610 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 00888479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Life Threatening| H| O