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 Code	Epistaxis (4458)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bleeding is a known potential adverse effect releated to the use of radiofrequency energy on tissue in the nose.
Event or Problem Description
Patient presented to the emergency department 48 hours following a rhinaer procedure with bilateral epistaxis.Patient had a bilateral sphenopalatine artery ligation and stayed in the hospital overnight.

• 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: michael agresto ; 2565 leghorn st.; mountain view, CA 94043 ; 7328501584
• MDR Report Key: 25337279
• Report Number: 3011625895-2026-00004
• Device Sequence Number: 5368918
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: 08886479300238
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 05/05/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White