BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 19571428 · Received June 19, 2024

    Report

    Report Number
    3011625895-2024-00005
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 19, 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

    PATIENT WAS TREATED WITH RHINAER. A FEW DAYS AFTER THE TREATMENT, THE PATIENT RETURNED COMPLAINING OF NOSEBLEED. PHYSICIAN ASSESSED AND SENT THE PATIENT HOME. THE PATIENT WENT TO ER WAS TREATED WITH BALLOON NASAL PACKING AND RELEASED. PATIENT RETURNED TO ER AND WAS ADMITTED FOR MONITORING OVERNIGHT PER PHYSICIAN REQUEST. PATIENT WAS RELEASED NEXT DAY WITH NO BLOOD TRANSFUSION REQUIRED. THERE WAS NO REPORT OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512894 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 10152 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| H