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

Model Number FG-001-00025

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 06/05/2019

Event Type  Injury  

Event 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
• Type of Device: ULTRASONIC SCALER
• Manufacturer (Section D): SONENDO, INC.; 26061 merit circle, suite 102; laguna hills, ca
• Manufacturer Contact: angela chen ; 26061 merit circle, suite 102; laguna hills, ca ; 7663636801
• MDR Report Key: 9863292
• MDR Text Key: 196426376
• Report Number: 3010817521-2019-00001
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 00858395006301
• UDI-Public: 00858395006301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: FG-001-00025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 03/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other