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	07/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
None.
Event or Problem Description
Patient had history of multiple nasal and sinus procedures including total sinus surgery by another surgeon, mega-antrostomies, and scar present in operative region.Patient presented with cough and postnasal drainage.Scar was seen in operative area and changes present from prior surgery.Rhinaer was performed under mild sedation with local and topical anesthesia.There were a few areas treated along the course of the posterior nasal nerve.No treatments were overlapped.There was nothing unusual about the procedure.Post procedure patient was given antibiotic, cephalexin, topical mupirocin, and instructed to use saline rinse.Two week follow up, treatment site was unremarkable and cough had improved.Days following two week follow up, the patient began epistaxis while at home.Went by ems to emergency department.By the time of arrival, bleeding ceased.Bleeding was treated with rhino rocket epistaxis device.Minimal time spent at ed.Two days later, bleeding recurred bilaterally and the patient was seen in physician office.Bleeding was posterior.Patient was transferred to hospital where an embolization was done to the internal maxillary and sphenopalatine arteries bilaterally.Patient was also transfused.There has been no further bleeding and patient has done well.

• 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 SINGAPORE PTE. LTD.; 60 albert street #16-01; singapore 18996 9; SN 189969
• Manufacturer Contact: shannon scott ; 2565 leghorn st.; mountain view, CA 94043 ; 5122219956
• MDR Report Key: 20132158
• Report Number: 3011625895-2024-00007
• Device Sequence Number: 7297381
• 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): 09/03/2024

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
• 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: 08/02/2024
• Initial Report FDA Received Date: 09/04/2024
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female