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 Code	Swelling (2091)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reported that the patient had a hypochlorite extrusion into the facial tissues.The patient had immediate pain and swelling followed by bruising.Patient sought follow up emergency treatment for pain.Patient seemed okay at 6 week follow up.

• 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: 9863292
• Report Number: 3010817521-2019-00001
• Device Sequence Number: 3431994
• 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): 08/26/2019

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: 08/15/2019
• 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