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

Model Number FG-002-00001

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dysphasia (2195); Skin Burning Sensation (4540); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/10/2021

Event Type  Injury  

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 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 Description

See initial report.

• Brand Name: SONENDO GENTLEWAVE SYSTEM
• Type of Device: ULTRASONIC SCALER
• Manufacturer (Section D): SONENDO, INC.; 26061 merit circle, suite 102; laguna hills CA 92653
• MDR Report Key: 11599848
• MDR Text Key: 243326734
• Report Number: 3010817521-2021-00001
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 00858395006226
• UDI-Public: 00858395006226
• Combination Product (y/n): N
• PMA/PMN Number: K160905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: FG-002-00001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other