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

Model Number FG815

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Epistaxis (4458)

Event Date 06/13/2021

Event Type  Injury  

Manufacturer Narrative

Bleeding is a known potential adverse event and documented in the device labeling.

Event 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
• Type of Device: RADIOFREQUENCY PROBE
• Manufacturer (Section D): AERIN MEDICAL INC.; 232 e caribbean drive; sunnyvale CA 94089
• Manufacturer (Section G): AERIN MEDICAL SINGAPORE PTE. LTD.; 60 albert street #16-01; singapore 18996 9; SN 189969
• Manufacturer Contact: shannon scott ; 232 e caribbean drive; sunnyvale, CA 94089 ; 5122219956
• MDR Report Key: 12170971
• MDR Text Key: 261663763
• Report Number: 3011625895-2021-00004
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 08886479300184
• UDI-Public: 08886479300184
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 61