MAUDE Adverse Event Report: VISTA-DENTAL TRITON IRRIGATION SOLUTION

Catalog Number	5028425U0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient went to the doctor due to pain on (b)(6) 2023.The doctor reported irreversible pulpitis/ early necrosis with sap and performed an emergency pulpectomy on tooth 45 (ada 29).A 30 ga vented irrigation needle mounted on 5cc luer lock syringe was used.Also, a rubber dam isolation and high vol suction with narrow bore and large bore evacuation tips were used.Nothing notable occurred during the procedure.The doctor said they followed the instructions for use; however, the instructions say keep refrigerated but the doctor said they may not have been as diligent to keep the product there when needing it handy for procedures so they store it in a climate-controlled cupbord away from light where similar materials are stored.No air bubbles were noticed.The cap was placed on with the arrows the correct way.The pain did not go away and the patient reported swelling in the lower right jaw region the same evening.The doctor prescribed amoxycillin 500mg tid for 7 days and then azithromycin 500mg od for 5 days.The patient's pain level started to reduce on (b)(6) 2023 but there was still a hard indurated swelling in the vestibule.

• Brand Name: TRITON IRRIGATION SOLUTION
• Common Device Name: IRRIGATION SOLUTION
• Manufacturer (Section D): VISTA-DENTAL; 2200 south street; racine WI 53404
• MDR Report Key: 18221936
• Report Number: 1032227-2023-00006
• Device Sequence Number: 6748210
• Product Code: KJJ
• UDI-Device Identifier: 00887919884699
• UDI-Public: (01)00887919884699(17)250330(10)20232015
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/28/2023
• Report Date (Section F): 11/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2025
• Device Catalogue Number: 5028425U0
• Device Lot Number: 20232015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/03/2023
• Event Location: Other
• Date Report to Manufacturer: 11/28/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 11/28/2023