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

Model Number	FG815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Epistaxis (4458)
Date of Event	07/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient was treated with the rhinaer stylus.Patient does not have a history of nose bleeds but bled during the anesthesia injection.Patient was treated in 3 locations in the basal lamella area and 3 locations along the inferior turbinate on both sides.Two weeks post-treatment on 7/24/2022, the patient was admitted to the er with epistaxis of both nostrils.Patient required bilateral embolization to stop bleeding and received a blood transfusion (3 units).Bleeding occurred in the basal lamella area.Patient was admitted to the hospital and released home on (b)(6) 2022.
Additional Manufacturer Narrative
Bleeding is a known potential adverse event and documented in the device labeling.
Event or Problem Description
The patient was treated with the rhinaer stylus.Two weeks post-treatment with rhinaer stylus, the patient was admitted to the er with epistaxis of both nostrils.Patient required bilateral embolization to stop bleeding and received a blood transfusion.Patient was released home after treatment.New information recieved 03 oct 2023: a 37-year-old woman with longstanding history of cr and nasal bone fracture s/p multiple functional endoscopic sinus surgeries and septoplasty x3 presented to the ed with severe bilateral epistaxis 12 days after temperature-controlled radiofrequency neurolysis of the pnn (rhinaer) by initial reporting ent physician.She reported onset of epistaxis after bending down to lift her child.Bilateral anterior and posterior nasal packing stopped the active bleeding, and the patient was admitted to the icu.She had three episodes of recurrent epistaxis despite nasal packing.Her hemoglobin dropped from 11.6 g/dl at admission to 7.3 g/dl.The patient was transfused with two units of prbcs and emergently taken to the or for coil embolization of bilateral sphenopalatine (spa) and internal maxillary (ima) arteries.On pod #1 , she received an additional unit of prbc for symptomatic anemia.She was discharged home with nasal saline spray.The patient had no epistaxis, nasal crusting, or nasal dryness at 4 month follow up at our institution, however reported intermittent mild epistaxis and dry nasal crusting at 8 month follow up at an outside hospital.
Additional Manufacturer Narrative
Bleeding is a known potential adverse event and documented in the device labeling.The new information was received by the treating physician in the ed.Dr.(b)(6).

• 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: 15290140
• Report Number: 3011625895-2022-00001
• Device Sequence Number: 11335726
• Product Code: GEI
• UDI-Device Identifier: 08886479300184
• UDI-Public: 08886479300184
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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: FG815
• Device Catalogue Number: CAT821
• 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: 07/25/2022
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other; Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White