BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITON IRRIGATION SOLUTION

    MDR report key: 18221936 · Received November 28, 2023

    Report

    Report Number
    1032227-2023-00006
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    October 30, 2023
    Report Date
    November 28, 2023
    Manufacturer
    VISTA-DENTAL
    Product Code
    KJJ
    UDI-DI
    00887919884699
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546438 TRITON IRRIGATION SOLUTION IRRIGATION SOLUTION KJJ VISTA-DENTAL 20232015 00887919884699

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention