BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINAER STYLUS

    MDR report key: 22343136 · Received June 27, 2025

    Report

    Report Number
    3011625895-2025-00008
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    May 23, 2025
    Report Date
    June 26, 2025
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    08886479300238
    PMA / PMN Number
    K221907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NONE

    Description of Event or Problem · 0

    AERIN REPRESENTATIVE REPORTED THAT THE PHYSICIAN BENT THE STYLUS SHAFT TOO CLOSE TO THE TIP AND APPLIED TOO MUCH PRESSURE DURING USE. THE TIP BROKE. THE LOOSE COMPONENT WAS RETRIEVED FROM THE NASAL PASSAGE. NO PATIENT INJURY OR COMPLICATION WERE REPORTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972880 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. CAT1394 39246 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown