BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 20356310 · Received October 2, 2024

    Report

    Report Number
    3011625895-2024-00010
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    August 28, 2024
    Report Date
    October 2, 2024
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    08886479300238
    PMA / PMN Number
    K221907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NONE.

    Description of Event or Problem · 0

    PATIENT WAS TREATED WITH RHINAER (PNN, SEPTAL SWELL BODIES, INFERIOR TURBINATES). PATIENT IS ON PLAVIX, WHICH WAS HALTED FOR 48 HOURS PRIOR TO TREATMENT AND RESUMED SHORTLY FOLLOWING TREATMENT. PATIENT PRESENTED WITH NOSEBLEED 8 DAYS POST-OPERATIVELY AND AT TIME OF REPORT WAS STILL IN THE HOSPITAL. THE TREATING ENT REPORTED THAT THE PATIENT WAS BLEEDING IMMEDIATELY POST-OPERATIVELY ALONG THE SEPTUM, WHICH WAS ADDRESSED WITH SILVER NITRATE. THE PATIENT WAS SEEN BY AN ENT IN THE ER FOR THE DELAYED BLEEDING EVENT WHO PLACED A RHINO ROCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905307 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Hospitalization| O