BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINAER STYLUS

    MDR report key: 23459547 · Received November 3, 2025

    Report

    Report Number
    3011625895-2025-00014
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    September 5, 2025
    Report Date
    November 3, 2025
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    08886479300238
    PMA / PMN Number
    K221907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS INITIALLY ASSESSED TO BE NOT REPORTABLE DUE TO LIMITED AVAILABLE DATA. DEVICE WAS RECEIVED FOR INVESTIGATION ON 22-SEP-2025 AND THE INVESTIGATION WAS COMPLETED ON 28-OCT-2025. UPON COMPLETION OF THE INVESTIGATION, THE EVENT WAS DETERMINED TO BE REPORTABLE AND REPORTED ON 03-NOV-2025.

    Description of Event or Problem · 0

    THE BACK OF THE RHINAER STYLUS TIP DETACHED FROM THE DEVICE DURING THE PROCEDURE CAUSING THE TIP TO SLIGHTLY SLIDE. THE PHYSICIAN SCOPED AND SUCTIONED THE NASAL AIRWAY. THE DETACHED COMPONENT WAS NOT RECOVERED. THE RHINAER STYLUS WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY OR COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533830 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 10245 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown