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 10/10/2019

Event Type  Injury  

Event Description

The procedure was on patient's upper molar.About 90 seconds into the naoci cycle, the patient raised her hands and said she was feeling pain.The doctor discontinued the gentlewave procedure, rinsed with distilled water.Swelling and bruising was noted very quickly.The doctor sent the patient to the ent in the building.The patient was given an rx for steroids and pain meds.The patient had swelling and bruising for a few weeks but it eventually resolved and she is doing fine.

• 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: 9863287
• MDR Text Key: 196426645
• Report Number: 3010817521-2020-00002
• 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: 01/06/2020

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: 12/10/2019
• 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