BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 19389212 · Received May 24, 2024

    Report

    Report Number
    3011625895-2024-00002
    Event Type
    Injury
    Date Received
    May 24, 2024
    Date of Event
    April 23, 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
    WV, 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. THIS SIDE EFFECT IS LISTING IN THE DEVICE LABELING.

    Description of Event or Problem · 0

    THE PATIENT WAS SEEKING TREATMENT FOR NASAL OBSTRUCTION, CHRONIC RHINITIS, AND CHRONIC SINUSITIS. THE PATIENT WAS NOT ON ANTICOAGULANT OR ANTIPLATELET THERAPY, DOES NOT HAVE A HISTORY OF HYPERTENSION OR ABNORMAL BLEEDING, AND IS A FORMER SMOKER WHO DISCONTINUED 13 YEARS AGO. THE PHYSICIAN PERFORMED A BALLOON SINUPLASTY, INFERIOR TURBINATE REDUCTION, VIVAER, AND RHINAER WITHOUT COMPLICATION. THE PHYSICIAN SAW THE PATIENT IN HIS OFFICE APPROXIMATELY 18 DAYS LATER, AT WHICH TIME ENDOSCOPIC INSPECTION REVEALED NORMAL HEALING WITH NO EVIDENCE OF BLEEDING OR SCABBING IN THE RHINAER TREATMENT AREA. FIVE DAYS LATER, THE PATIENT EXPERIENCED A NOSEBLEED AND PRESENTED AT THE ER. THE PATIENT RECEIVED BILATERAL NASAL PACKING AND WAS DISCHARGED TO HOME. THE NEXT DAY THE PATIENT PRESENTED AT A DIFFERENT ER WITH BLEEDING AND WAS FOUND TO BE HYPOTENSIVE AND TACHYCARDIC WITH A LOW HEMOGLOBIN LEVEL. THE PATIENT WAS TAKEN TO THE OR. ENDOSCOPIC INSPECTION OF THE AREA REVEALED ACTIVE BLEEDING IN THE POSTERIOR MIDDLE MEATUS. THE BLEEDING AREA WAS CAUTERIZED WHICH RESULTED IN CESSATION OF BLEEDING. THE PATIENT WAS GIVEN A 2-UNIT BLOOD TRANSFUSION. THE PATIENT WAS TAKEN THE ICU FOR OBSERVATION AND DISCHARGED TO HOME WITH A NORMAL HEMOGLOGIN LEVEL AND WITHOUT FURTHER COMPLICATION. THE PHYSICIAN IS CLOSELY FOLLOWING THE PATIENT'S PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300109 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 33156 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Hospitalization| O