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

Model Number	FG-002-00001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Fluid Discharge (2686)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: ULTRASONIC SCALER
• Manufacturer (Section D): SONENDO; 26061 merit circle, suite 102; laguna hills, ca
• MDR Report Key: 9736218
• Report Number: 3010817521-2020-00001
• Device Sequence Number: 1974245
• Product Code: ELC
• UDI-Device Identifier: 00858395006226
• UDI-Public: 00858395006226
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: FG-002-00001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 02/20/2020
• 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