MAUDE Adverse Event Report: SONENDO, INC. SONENDO GENTLEWAVE SYSTEM; ULTRASONIC SCALER

Model Number	FG-002-00001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reported that the patient had nose bleeding after completing the gentlewave procedure.The next day the patient reported nasal drainage; and it continued for two days.After two weeks, the patient was sent to an ent doctor and was diagnosed with oro-antra fistula.

• Brand Name: SONENDO GENTLEWAVE SYSTEM
• Common Device Name: ULTRASONIC SCALER
• Manufacturer (Section D): SONENDO, INC.; 26061 merit circle, suite 102; laguna hills, ca
• MDR Report Key: 9984692
• Report Number: 3010817521-2019-00002
• Device Sequence Number: 4356136
• Product Code: ELC
• UDI-Device Identifier: 00858395006226
• UDI-Public: 00858395006226
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2020

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: FG-002-00001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 04/22/2020
• 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