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	01/10/2021
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
33 days post procedure, patient presented to the emergency department with complaint of ongoing worsening nosebleed for past 2 days.Patient stated that the nosebleed presented 2 days ago for the first time when patient tried to blow nose.Patient was taken to the local er where packing was done and patient was discharged home.Patient had a second episode when a family member attempted to put tampons in nose but when bleeding was not controlled patient was brought into the emergency department via ems.On ems arrival patient was noted to be hypotensive and tachycardic, patient received 2 g of txa, 2250 cc of iv fluid, and was given 1 unit of blood in the emergency department on arrival and another unit afterwards.Ent physician was notified.Patient underwent cauterization of right posterior nasal bleed and removal of blood clots by ent physician.Hb remained stable.Patient was discharged same day of the procedure.Clinic has confirmed that patient is doing well now.

• 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: 11262689
• Report Number: 3011625895-2021-00002
• Device Sequence Number: 2564041
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 05/01/2022
• Device Model Number: FG815
• Device Catalogue Number: CAT821
• Device Lot Number: 10006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/01/2021
• 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: Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 84