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	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received on june 4, 2022 regarding a bleeding event 2 weeks post-procedure following treatment in the pnn area with a rhinaer stylus.The treatment with rhinaer stylus was completed in the or in conjunction with a co-physician rhinoplasty.It was reported that bleeding has resolved and healed with no further incident as of (b)(6) 2022.The treating ent physician attributed the cause of the bleeding to a hard scab dislodging due to lack of patient compliance of irrigation protocol.The surgeon that completed the rhinoplasty instructed the patient not to irrigate per their normal rhinoplasty procedure protocol.The bleeding event was initially determined to be not reportable.Additional information regarding the event was requested and pending.On july 26, 2022, company representative provided additional information indicating that the patient required medical/surgical intervention to stop the bleeding.This new information regarding surgical invention required the event to be reported.The patient (approximately 40 years old) was treated with the rhinaer stylus on the right side in (b)(6) 2022 (exact date not known).Two weeks post-procedure, the patient presented at the er and was transferred to the operating room for bovie cauterization to stop the bleeding.The patient was held overnight for observation.Bleeding has resolved and healed with no further incident.Note: date of bleeding event has been submitted as (b)(6) 2022 since exact date is unknown.
Additional Manufacturer Narrative
Bleeding is a known potential adverse event and documented in the device labeling.

• 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: 15299351
• Report Number: 3011625895-2022-00003
• Device Sequence Number: 20617762
• Product Code: GEI
• UDI-Device Identifier: 08886479300184
• UDI-Public: 08886479300184
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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: 07/26/2022
• Initial Report FDA Received Date: 08/25/2022
• 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: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian