MAUDE Adverse Event Report: SONENDO SONENDO GENTLEWAVE SYSTEM; ULTRASONIC SCALER

Model Number FG-002-00001

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Fluid Discharge (2686)

Event Date 10/10/2019

Event Type  Injury  

Event Description

The procedure was on patient's upper molar with large mucus cyst above root.The doctor said he followed the recommended guidelines and when he was 90 seconds into the naoci cycle, the patient raised her hand and said that she had felt a shooting pain and tasted fluid draining in her mouth.The pain resolved quickly but the drainage continued.The dr.Discontinued the use of the gentlewave and rinsed with distilled water.The drainage persisted, no bleeding was noted but the dr.Was unable to stop the drainage so he medicated the tooth and sent the patient to an ent in the building.The pain did resolve prior to the patient leaving the office but some swelling was noted.The ent did a ct and noted that everything looked the same as the original cbct done by the dr (infection at root) with exception that the mucus cyst was no longer present.Patient was sent home with antibiotics, pain meds and steroids.Patient returned a week later, swelling resolved; patient denied any issues, tooth was cleaned and obturated.No further complaint.

• Brand Name: SONENDO GENTLEWAVE SYSTEM
• Type of Device: ULTRASONIC SCALER
• Manufacturer (Section D): SONENDO; 26061 merit circle, suite 102; laguna hills, ca
• Manufacturer Contact: angela chen ; 26061 merit circle, suite 102; laguna hills, ca ; 7663636801
• MDR Report Key: 9736218
• MDR Text Key: 192493855
• Report Number: 3010817521-2020-00001
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 00858395006226
• UDI-Public: 00858395006226
• 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: Dentist
• Type of Report: Initial
• Report Date: 02/20/2020

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-002-00001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other