BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINAER STYLUS

    MDR report key: 15548967 · Received October 6, 2022

    Report

    Report Number
    3011625895-2022-00006
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 7, 2022
    Report Date
    October 5, 2022
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    08886479300184
    PMA / PMN Number
    K192471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRIOR TO USE OF THE RHINAER STYLUS, A PIECE OF THE TREATMENT TIP OF THE STYLUS WAS FOUND TO BE LOOSE. THE NURSE SNAPPED THE PIECE INTO PLACE AND TESTED THE DEVICE. THE PIECE DID NOT APPEAR TO BE LOOSE AND REMAINED INTACT. DURING THE PROCEDURE ON THE RIGHT SIDE, A PIECE OF THE TREATMENT TIP CAME OFF IN THE PATIENT'S NASOPHARYNX. THE PATIENT'S AIRWAY WAS EVALUATED WITH A FLEXIBLE ENDOSCOPE DOWN TO THE CARINA. NO FOREIGN BODIES WERE NOTED. THE PATIENT WAS ALERTED TO AND AWARE OF WHAT HAPPENED. TWO WEEKS POST-PROCEDURE, THE PATIENT WAS REPORTED AS DOING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150025 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG815 10051 08886479300184

    Patients

    Seq Age Sex Outcome Treatment
    1 Female