BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 15299351 · Received August 25, 2022

    Report

    Report Number
    3011625895-2022-00003
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    April 14, 2022
    Report Date
    August 25, 2022
    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. THE TREATMENT WITH RHINAER STYLUS WAS COMPLETED IN THE OR IN CONJUNCTION WITH A CO-PHYSICIAN RHINOPLASTY. IT WAS REPORTED THAT BLEEDING HAS RESOLVED AND HEALED WITH NO FURTHER INCIDENT AS OF (B)(6) 2022. THE TREATING ENT PHYSICIAN ATTRIBUTED THE CAUSE OF THE BLEEDING TO A HARD SCAB DISLODGING DUE TO LACK OF PATIENT COMPLIANCE OF IRRIGATION PROTOCOL. THE SURGEON THAT COMPLETED THE RHINOPLASTY INSTRUCTED THE PATIENT NOT TO IRRIGATE PER THEIR NORMAL RHINOPLASTY PROCEDURE PROTOCOL. 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 THAT THE PATIENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO STOP THE BLEEDING. THIS NEW INFORMATION REGARDING SURGICAL INVENTION REQUIRED THE EVENT TO BE REPORTED. THE PATIENT (APPROXIMATELY 40 YEARS OLD) WAS TREATED WITH THE RHINAER STYLUS ON THE RIGHT SIDE IN (B)(6) 2022 (EXACT DATE NOT KNOWN). TWO WEEKS POST-PROCEDURE, THE PATIENT PRESENTED AT THE ER AND WAS TRANSFERRED TO THE OPERATING ROOM FOR BOVIE CAUTERIZATION TO STOP THE BLEEDING. THE PATIENT WAS HELD OVERNIGHT FOR OBSERVATION. BLEEDING HAS RESOLVED AND HEALED WITH NO FURTHER INCIDENT. NOTE: DATE OF BLEEDING EVENT HAS BEEN SUBMITTED AS (B)(6) 2022 SINCE EXACT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472121 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG815 08886479300184

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention