BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 19534461 · Received June 13, 2024

    Report

    Report Number
    3011625895-2024-00004
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 11, 2024
    Report Date
    July 30, 2024
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    08886479300238
    PMA / PMN Number
    K221907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOSE BLEEDS ARE A KNOWN POTENTIAL SIDE EFFECT RELATED TO THE USE OF RADIOFREQUENCY ENERGY ON THE TISSUE IN THE NOSE. IT IS LISTED IN THE DEVICE LABELING AS A POTENTIAL ADVERSE EFFECT.

    Description of Event or Problem · 0

    THE PATIENT IS IN LATE 70S (ESTIMATED TO BE 76) WITH A HISTORY OF CHRONIC NASAL OBSTRUCTION AND CHRONIC RHINITIS. THE PATIENT WAS ON ANTICOAGULANT THERAPY. THE PHYSICIAN BELIEVES ANTICOAGULANT THERAPY WAS DISCONTINUED PRIOR TO RHINAER TREATMENT. THE PATIENT RECEIVED TREATMENT TO THE PNN AREA AND THE INFERIOR TURBINATE UNDER LOCAL ANESTHESIA IN THE OFFICE. THERE WERE NO POST TREATMENT ISSUES AT 2 WEEK FOLLOW UP. AT 1 MONTH POST PROCEDURE THE PATIENT WAS ON VACATION AND EXPERIENCED A NASAL BLEEDING EVENT ON THE LEFT SIDE. THE PATIENT WENT TO THE ER AND WAS SEEN BY ENT PHYSICIAN WHO REFERRED THE PATIENT FOR EMBOLIZATION OF THE ARTERY, WHICH STOPPED THE BLEEDING. THE PATIENT WAS REPORTED TO BE DOING WELL. NO DEVICE PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390833 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 UNKNOWN 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention| O