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

Model Number FG-001-00025

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Date 02/11/2020

Event Type  Injury  

Event Description

After 4 minutes into the naoci cycle, the patient jumped out of the chair and said he could not breath.There was bleeding from the tooth, but not excessive.The doctor thought patient ingested some naoci so he gave the patient water to rinse; and after few minutes the patient was able to continue with the treatment.The treatment was completed.The patient did not have swelling or bruising at the time.However, the patient was in er that night when the doctor called to follow-up.The patient stated he had excessive amount of nose bleed and had difficulty in breathing.The patient was sent home with augmentin 875mg every 12 hours for 7 days.After 8 days following the incident, the patient claimed he was still congested, but nose bleeding had stopped.The patient has a follow-up appointment with his physician (general practitioner).The doctor asked the patient to schedule an appointment following the appointment with his physician.

• 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: 9863280
• MDR Text Key: 196426368
• Report Number: 3010817521-2020-00003
• 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: 03/20/2020

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: 02/21/2020
• 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