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

Model Number	FG-002-00001
Health Effect - Clinical Codes	Dysphasia (2195); Skin Burning Sensation (4540); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The doctor returned procedure instrument (pi) used with the patient and the pi was tested by sonendo.No defect of product alleged.Device history record of the pi was reviewed; no nonconformities in the dhr.With respect to the patient's comments regarding the reported incident, the manufacturer has not received any communication from a medical professional to confirm or deny the patient's report to the doctor.The doctor indicates patient is no longer communicating with him, despite several attempts to contact.
Event or Problem Description
The doctor reported that while working on tooth#2 in a necrotic treatment, there was foaming at the platform.The doctor readjusted a couple times but the foaming continued, patient reported tasting bleach.He interrupted the treatment.The doctor described that the patient had burning in the throat.He followed up with the patient for 10 days and the patient reported she was very hoarse and lost her voice and missed work.The patient self-referred to er, ent and voice therapy.The doctor continued to follow up with the patient, but after 10 days the patient stopped responding to his messages and missed follow up to finish the treatment.
Event or Problem Description
See initial report.

• Brand Name: SONENDO GENTLEWAVE SYSTEM
• Common Device Name: ULTRASONIC SCALER
• Manufacturer (Section D): SONENDO, INC.; 26061 merit circle, suite 102; laguna hills CA 92653
• MDR Report Key: 11599848
• Report Number: 3010817521-2021-00001
• Device Sequence Number: 19835930
• Product Code: ELC
• UDI-Device Identifier: 00858395006226
• UDI-Public: 00858395006226
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/29/2021
• 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