BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 20220082 · Received September 14, 2024

    Report

    Report Number
    3011625895-2024-00009
    Event Type
    Injury
    Date Received
    September 14, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 14, 2024
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    08886479300238
    PMA / PMN Number
    K221907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NONE

    Description of Event or Problem · 0

    PRIOR TO TREATMENT WITH THE RHINAER STYLUS, BOTH TOPICAL AND INJECTABLE LOCAL ANESTHESIA WERE ADMINISTERED. PATIENT WAS THEN TREATED WITH THE RHINAER STYLUS. PHYSICIAN TREATED 6-9 LOCATIONS ON EACH SIDE IN THE POSTERIOR NASAL NERVE REGIONCO, THEN TREATED A COUPLE ON EACH INFERIOR TURBINATE. THE POSTERIOR EDGE OF THE INFERIOR TURBINATE WAS THE MOST POSTERIOR TREATMENT SITE. NO OTHER PROCEDURES WERE PERFORMED. EIGHTEEN DAYS POST-PROCEDURE THE PATIENT EXPERIENCED A NOSEBLEED AND CALLED THE TREATING PHYSICIAN'S OFFICE. THE PHYSICIAN AT THE OFFICE INSTRUCTED THE PATIENT TO HOLD PRESSURE ON THEIR NOSE TO HELP STOP THE BLEED. THE BLEEDING DID NOT STOP. THE PATIENT WENT TO THE ER, WAS PACKED AND DISCHARGED. THE PATIENT WAS UNCOMFORTABLE BEING DISCHARGED AND WENT TO A DIFFERENT ER AND WAS ADMITTED. THE DURATION OF THE HOSPITALIZATION AT THE SECOND HOSPITAL IS UNKNOWN AT THIS TIME. THE EXACT LOCATION OF THE BLEEDING IS UNKNOWN. THE TREATING ENT WAS NOT PRESENT WHEN THE PATIENT PRESENTED TO THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667184 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| O