BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISTA DENTAL PRODUCTS - CHLOR - XTRA

    MDR report key: 10319923 · Received July 23, 2020

    Report

    Report Number
    MW5095699
    Event Type
    Injury
    Date Received
    July 23, 2020
    Date of Event
    August 31, 2019
    Report Date
    July 6, 2020
    Manufacturer
    VISTA DENTAL PRODUCTS / INTER-MED LLC
    Product Code
    KJJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    GENERAL DENTIST DURING ROOT CANAL OF TOOTH# 20 IMPROPERLY ADMINISTERED SODIUM HYPOCHLORITE WHICH LEACHED OUT OF MY TOOTH INTO SURROUNDING TISSUE AND NERVE. PRODUCT WAS VISTA DENTAL PRODUCTS CHLOR-XTRA CONTAINING 6% SODIUM HYPOCHLORITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782220 VISTA DENTAL PRODUCTS - CHLOR - XTRA CLEANSER, ROOT CANAL KJJ VISTA DENTAL PRODUCTS / INTER-MED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability