BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINAER STYLUS

    MDR report key: 21957357 · Received May 4, 2025

    Report

    Report Number
    3011625895-2025-00005
    Event Type
    Malfunction
    Date Received
    May 4, 2025
    Date of Event
    April 4, 2025
    Report Date
    May 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NONE.

    Description of Event or Problem · 0

    THE TREATMENT TIP OF THE RHINAER STYLUS SEPARATED DURING TREATMENT OF THE TURBINATE AT THE END OF PROCEDURE. THE HOUSING FOR THE ELECTRODES DETACHED FROM STYLUS. THE COMPONENT FELL ONTO THE "FLOOR OF THE NOSE" RIGHT BY THE ENTRANCE TO THE NOSE / NOSTRIL. THE BROKEN COMPONENT WAS EASILY IDENTIFIABLE BY THE PHYSICIAN AND WAS EASILY REMOVED. THE PROCEDURE COMPLETED AS PLANNED. NO PATIENT INJURY OR ISSUES REPORTED DUE TO THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475798 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 39259 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown