BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 23201575 · Received October 2, 2025

    Report

    Report Number
    3011625895-2025-00013
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    August 8, 2025
    Report Date
    October 2, 2025
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K221907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED WITH THE RHINAER STYLUS IN A SURGERY CENTER UNDER GENERAL ANESTHESIA. NO OTHER PROCEDURES WERE PERFORMED AT THE TIME OF THE RHINAER TREATMENT. LATER THE SAME DAY AS THE TREATMENT THE PATIENT PRESENTED TO URGENT CARE WITH BLEEDING AND WAS TREATED WITH SURGICEL. BLEEDING WAS CONTROLLED FOR 2 DAYS, THEN THE PATIENT PRESENTED TO THE ER WITH BILATERAL EPISTAXIS, BLEEDING FROM RIGHT MIDDLE ORBIT AND RIGHT EAR. RHINO ROCKET PLACED BILATERAL BUT REMOVED DUE TO PAIN. PATIENT HEMATOCRIT DROPPED TO 20 AND 2 UNITS OF PACKED RBC ADMINISTERED. TWO DAYS LATER, BILATERAL SPHENOPALATINE ARTERY EMBOLIZATION PERFORMED TO CONTROL BLEEDING. THE PHYSICIAN REPORTED THAT THE PATIENT HAS DONE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278562 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| O