BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINAER STYLUS

    MDR report key: 23040028 · Received September 12, 2025

    Report

    Report Number
    3011625895-2025-00012
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    February 27, 2024
    Report Date
    September 12, 2025
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    08886479300238
    PMA / PMN Number
    K221907
    Adverse Event
    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 GIVEN THE FAILURE WAS DETECTABLE AND NO INJURY OCCURRED. ON AUGUST 21, 2025, AN INTERNAL REVIEW OF SIMILAR MALFUNCTIONS CONCLUDED THAT THE EVENT WAS REPORTABLE CONSIDERING THAT A SERIOUS INJURY COULD OCCUR IF THE MALFUNCTION WERE TO RECUR IN A FUTURE SIMILAR EVENT. THIS DATE IS INDICATED AS THE "DATE RECEIVED BY MANUFACTURER".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN BENT THE STYLUS SHAFT TOO AGGRESSIVELY TOWARD THE TIP. THE DEVICE WAS THEN INSERTED IN THE NOSE IN THE POSTERIOR NASAL NERVE AREA. WHEN PRESSURE WAS APPLIED TO THE DEVICE, THE TIP BROKE AND A FRAGMENT DETACHED FROM THE STYLUS TIP. THE LOOSE COMPONENT WAS RETRIEVED FROM THE NASAL PASSAGE. NO PATIENT INJURY OR COMPLICATION WAS REPORTED. THE COMPANY REPRESENTATIVE REVIEWED PROPER BENDING PROCEDURE FOR THE DEVICE AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960213 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 39260 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown