BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 22465346 · Received July 9, 2025

    Report

    Report Number
    3011625895-2025-00009
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 9, 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

    Description of Event or Problem · 0

    PATIENT UNDERWENT UNCOMPLICATED TREATMENT WITH RHINAER STYLUS. 2.5 WEEKS POST-PROCEDURE THE PATIENT PRESENTED TO LOCAL EMERGENCY ROOM WITH BLEEDING INTO THE OROPHARYNX AND OUT THE LEFT NARIS. A SYNCOPAL EPISODE AND CONCERNS OF HEMODYNAMICS WERE NOTED. THE PATIENT WAS PACKED WITH A BALLOON, GIVEN 1 UNIT OF BLOOD AND TRANSFERRED TO ANOTHER HOSPITAL. PATIENT WAS TAKEN TO THE OR. SPHENOPALATINE ARTERY LIGATION WAS PERFORMED TO ACHIEVE HEMOSTASIS. ENDOSCOPIC INSPECTION OF CONTRALATERAL (RIGHT) SIDE SHOWED NO SIGNS OF MUCOSAL INTERRUPTION OR TRAUMA IN THE AREA OF AN ACCESSORY ARTERIAL BRANCH WITH VERY HEALTHY TISSUE SURROUNDING IT AND GOOD VIABLE MUCOSA. PATIENT WAS SEEN 5 DAYS POST-PROCEDURE AND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119981 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. CAT1394 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other| H