BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 15299352 · Received August 25, 2022

    Report

    Report Number
    3011625895-2022-00002
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 29, 2025
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    08886479300184
    PMA / PMN Number
    K192471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLEEDING IS A KNOWN POTENTIAL ADVERSE EVENT AND DOCUMENTED IN THE DEVICE LABELING.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED ON JUNE 4, 2022 REGARDING A BLEEDING EVENT 2 WEEKS POST-PROCEDURE FOLLOWING TREATMENT IN THE PNN AREA WITH A RHINAER STYLUS. IT WAS REPORTED THAT THE BLEEDING HAD RESOLVED AND HEALED WITH NO FURTHER INCIDENT AS OF (B)(6) 2022. THE TREATING ENT PHYSICIAN ATTRIBUTED THE CAUSE OF THE BLEEDING TO THE PATIENT'S LACK OF COMPLIANCE TO IRRIGATION PROTOCOL AND OTHER CO-MORBIDITIES (I.E., HEAVY SMOKER). THE BLEEDING EVENT WAS INITIALLY DETERMINED TO BE NOT REPORTABLE. ADDITIONAL INFORMATION REGARDING THE EVENT WAS REQUESTED AND PENDING. ON JULY 26, 2022, COMPANY REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THE PATIENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO STOP THE BLEEDING. IN CONSIDERING THE NEW INFORMATION, THE EVENT WAS DETERMINED TO BE REPORTABLE. THE PATIENT (APPROXIMATELY 60 YEARS OLD) WAS TREATED WITH RHINAER STYLUS ON LEFT SIDE IN (B)(6) 2022 (EXACT DATE NOT KNOWN). TWO WEEKS POST-PROCEDURE, THE PATIENT PRESENTED AT THE ER AND WAS TRANSFERRED TO OR FOR SPA LIGATION. THE PATIENT WAS HELD OVERNIGHT FOR OBSERVATION. BLEEDING HAS RESOLVED AND HEALED WITH NO FURTHER INCIDENT. DATE OF BLEEDING EVENT HAS BEEN SUBMITTED AS (B)(6) 2022 SINCE EXACT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED ON BOTH SIDES WITH RHINAER. THE BLEEDING EVENT OCCURRED ON ONE SIDE. THE PATIENT REPORTED 4 PINTS OF BLOOD LOSS AND REQUIRING EPINEPHRINE FOR RESUSCITATION AT THE TIME OF THE BLEEDING EVENT. THE TREATING PHYSICIAN COULD NOT CONFIRM THE RESUSCITATION EVENT. THREE YEARS FOLLOWING THE PROCEDURE, THE PATIENT REPORTS CONTINUED NASAL ISSUES AND BLEEDING, MOSTLY ON THE RIGHT BUT SOMETIMES ON THE LEFT SIDE. THE PATIENT IS CURRENTLY BEING TREATED WITH ANTIBIOTICS, STEROID AND USING NASAL RINSES. IT IS THE THIRD TIME FOR THIS TYPE OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472122 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG815 08886479300184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| L