MAUDE Adverse Event Report: AERIN MEDICAL INC. RHINAER STYLUS; RADIOFREQUENCY PROBE

Model Number	FG1393
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Epistaxis (4458)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a bilateral rhinaer procedure performed in the office under local, topical anesthesia with no injection.There were no other procedures performed and it went smoothly.Patient is not on anticoagulant medication.Ten (10) days post procedure the patient's family member called the office and relayed that the patient had concerning nasal bleeding from the right side.An ambulance was called and the patient was taken to the er.The treating ent physician did not have privileges at the hospital.The right side was packed with a rapid rhino but the bleeding continued and the left side also required packing with a rapid rhino.The patient required a blood transfusion and was admitted overnight.The patient was released the next morning with instruction to follow up with treating ent physician in 2-3 days, but started bleeding again before this appointment.The ent physician took him to the or and was able to visualize a bleeding branch of the spa on the right side.The location of the bleed was cauterized and a merocel pack was placed.The patient was again admitted overnight.The small packing was removed the next morning, no further bleeding was noted.The patient was discharged home.The patient followed up one week later and significant crusting was noted bilaterally on the anterior septum.The physician performed serial debridements.The posterior nasal cavity healed well but the anterior septum necrosed resulting in an approximately 1 cm septal perforation.At the last follow up (4-5 weeks following the event), the crusting had greatly improved and the patient did not have significant problems due to the perforation.The physician attributed the necrosis and eventual septal perforation to the nasal packing.

• Brand Name: RHINAER STYLUS
• Common Device Name: RADIOFREQUENCY PROBE
• Manufacturer (Section D): AERIN MEDICAL INC.; 2565 leghorn st.; mountain view CA 94043
• Manufacturer (Section G): AERIN MEDICAL INC.; 2565 leghorn st.; mountain view CA 94043
• Manufacturer Contact: shannon scott ; 2565 leghorn st.; mountain view, CA 94043 ; 5122219956
• MDR Report Key: 22527489
• Report Number: 3011625895-2025-00010
• Device Sequence Number: 9246862
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: 08886479300238
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FG1393
• Device Catalogue Number: CAT1394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Male