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

Model Number	FG-001-00025
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Hemorrhage/Blood Loss/Bleeding (1888); No Code Available (3191)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
After 4 minutes into the naoci cycle, the patient jumped out of the chair and said he could not breath.There was bleeding from the tooth, but not excessive.The doctor thought patient ingested some naoci so he gave the patient water to rinse; and after few minutes the patient was able to continue with the treatment.The treatment was completed.The patient did not have swelling or bruising at the time.However, the patient was in er that night when the doctor called to follow-up.The patient stated he had excessive amount of nose bleed and had difficulty in breathing.The patient was sent home with augmentin 875mg every 12 hours for 7 days.After 8 days following the incident, the patient claimed he was still congested, but nose bleeding had stopped.The patient has a follow-up appointment with his physician (general practitioner).The doctor asked the patient to schedule an appointment following the appointment with his physician.

• 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: 9863280
• Report Number: 3010817521-2020-00003
• Device Sequence Number: 10894216
• Product Code: ELC
• UDI-Device Identifier: 00858395006301
• UDI-Public: 00858395006301
• 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): 03/20/2020

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-001-00025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/21/2020
• 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