BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINAER STYLUS

    MDR report key: 24972596 · Received April 23, 2026

    Report

    Report Number
    3011625895-2026-00003
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 23, 2026
    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

    Description of Event or Problem · 0

    A STYLUS TREATMENT TIP SEPARATED WHILE PERFORMING A PROCEDURE, RESULTING IN A LOOSE COMPONENT IN THE NASAL PASSAGE. THE LOOSE COMPONENT FROM THE STYLUS TIP WAS RETRIEVED AND NO INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032793 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL, INC. FG1393 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown