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

Model Number	FG1393
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A stylus treatment tip separated while performing a procedure, resulting in a loose component in the nasal passage.The loose component from the stylus tip was retrieved and no injuries or complications were reported.

• 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
• MDR Report Key: 24972596
• Report Number: 3011625895-2026-00003
• Device Sequence Number: 10456111
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: 08886479300238
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG1393
• Device Catalogue Number: CAT1394
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/23/2026
• 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
• Patient Sex: Unknown