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 06/01/2021

Event Type  Injury  

Event Description

The patient received one treatment on both sides with rhinaer stylus in the posterior nasal nerve region, along with maxillary balloon sinuplasty and turbinate outfracture.No device malfunction reported.The patient was treated in the clinic under topical and local anesthesia.The patient was seen for planned follow-up visits.Some minor bleeding reported, then approximately 9 days post-procedure presented to the er with a bleed on one side and was packed.When packing was removed, a serious spa bleed developed.Patient required spa ligation to control bleeding, was held overnight for observation and required a blood transfusion.Event occured approximately 2 years ago, date of event is estimated.

Manufacturer Narrative

Bleeding is a known potential side effect related to the use of radiofrequency energy on tissue in the nose.This side effect is listed in the device labeling.

• Brand Name: RHINAER STYLUS
• Type of Device: 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: 17213804
• MDR Text Key: 317984734
• Report Number: 3011625895-2023-00003
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG815
• Device Catalogue Number: CAT821
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female