BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 20132158 · Received September 4, 2024

    Report

    Report Number
    3011625895-2024-00007
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    July 15, 2024
    Report Date
    September 3, 2024
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    08886479300238
    PMA / PMN Number
    K221907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NONE.

    Description of Event or Problem · 0

    PATIENT HAD HISTORY OF MULTIPLE NASAL AND SINUS PROCEDURES INCLUDING TOTAL SINUS SURGERY BY ANOTHER SURGEON, MEGA-ANTROSTOMIES, AND SCAR PRESENT IN OPERATIVE REGION. PATIENT PRESENTED WITH COUGH AND POSTNASAL DRAINAGE. SCAR WAS SEEN IN OPERATIVE AREA AND CHANGES PRESENT FROM PRIOR SURGERY. RHINAER WAS PERFORMED UNDER MILD SEDATION WITH LOCAL AND TOPICAL ANESTHESIA. THERE WERE A FEW AREAS TREATED ALONG THE COURSE OF THE POSTERIOR NASAL NERVE. NO TREATMENTS WERE OVERLAPPED. THERE WAS NOTHING UNUSUAL ABOUT THE PROCEDURE. POST PROCEDURE PATIENT WAS GIVEN ANTIBIOTIC, CEPHALEXIN, TOPICAL MUPIROCIN, AND INSTRUCTED TO USE SALINE RINSE. TWO WEEK FOLLOW UP, TREATMENT SITE WAS UNREMARKABLE AND COUGH HAD IMPROVED. DAYS FOLLOWING TWO WEEK FOLLOW UP, THE PATIENT BEGAN EPISTAXIS WHILE AT HOME. WENT BY EMS TO EMERGENCY DEPARTMENT. BY THE TIME OF ARRIVAL, BLEEDING CEASED. BLEEDING WAS TREATED WITH RHINO ROCKET EPISTAXIS DEVICE. MINIMAL TIME SPENT AT ED. TWO DAYS LATER, BLEEDING RECURRED BILATERALLY AND THE PATIENT WAS SEEN IN PHYSICIAN OFFICE. BLEEDING WAS POSTERIOR. PATIENT WAS TRANSFERRED TO HOSPITAL WHERE AN EMBOLIZATION WAS DONE TO THE INTERNAL MAXILLARY AND SPHENOPALATINE ARTERIES BILATERALLY. PATIENT WAS ALSO TRANSFUSED. THERE HAS BEEN NO FURTHER BLEEDING AND PATIENT HAS DONE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056283 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 08886479300238

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| O| R