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	06/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bleeding is a known potential adverse event and documented in the device labeling.
Event or Problem Description
The rhinaer stylus was used to treat the posterior nasal nerve region of the nasal airway.Both right and left side were treated.Five days post-procedure, the patient went to the er due to bleeding.Bleeding was on the left side of nose, posterior aspect.Bleeding was controlled with a latex balloon.The physician saw the patient the day after the bleeding event and the next day.Patient is doing well.There was no report of device malfunction by the clinic.Physician reported on 07/13/2021 that she had seen the patient again and that the patient is doing well.

• Brand Name: RHINAER STYLUS
• Common Device Name: RADIOFREQUENCY PROBE
• Manufacturer (Section D): AERIN MEDICAL INC.; 232 e caribbean drive; sunnyvale CA 94089
• MDR Report Key: 12170971
• Report Number: 3011625895-2021-00004
• Device Sequence Number: 19205660
• Product Code: GEI
• UDI-Device Identifier: 08886479300184
• UDI-Public: 08886479300184
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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 Expiration Date: 04/01/2022
• Device Model Number: FG815
• Device Catalogue Number: CAT821
• Device Lot Number: 10005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 61