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 08/06/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2022 during an on-site visit, a physician reported treating a patient that presented in the er on (b)(6) 2022 with a severe nosebleed.The patient had been treated with the rhinaer stylus two weeks prior by another physician.The patient required suction and bovie on the left side.The patient was admitted to the hospital and released on (b)(6) 2022.The patient received a couple units of blood and platelets.The patient was currently taking clavix (blood thinner).

• 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: 15526106
• MDR Text Key: 301006117
• Report Number: 3011625895-2022-00005
• 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: 10/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• 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; Required Intervention