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

Model Number	UNKNOWN
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The handpiece when used with the console is referred to as the gentlewave system.Neither single use device/handpiece nor the console was returned for evaluation.Since the handpiece was not returned, the model and lot number could not be determined.This is sonendo's first electronic report and is late due to the enrollment process.
Event or Problem Description
The customer reported that a patient treated earlier in the day had gone to the hospital due to swelling in the neck, no bruising or bleeding was reported.Customer subsequently reported that patient was administered a breathing tube which has since been removed.The customer reported that the patient was discharged form the hospital and returned home.Endodontist (customer/user) initially stated that swelling could have been due to an allergic reaction to anesthesia.The customer subsequently stated that it could be a sodium hypochlorite incident.The customer reported that during the procedure, the patient indicated feeling pain and thus the customer re-anesthetized the patient.After administering more anesthesia, the customer reported that he completed the procedure and noted that the results looked good.The customer reported that the patient was fine after the procedure and left the office without issue.Since the time of the initial event, the customer has noted that the patient's condition is improving.

• Brand Name: GENTLEWAVE SYSTEM
• Common Device Name: ULTRASONIC SCALER
• Manufacturer (Section D): SONENDO, INC.; 26061 merit circle; suite 102; laguna hills CA 92653
• MDR Report Key: 7239913
• Report Number: 3010817521-2018-00001
• Device Sequence Number: 19139795
• Product Code: ELC
• UDI-Device Identifier: 00858395006226
• UDI-Public: 00858395006226
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: 160905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/13/2018

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: Dentist
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 02/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention