BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVER DIAMMINE FLOURIDE 38%

    MDR report key: 17931500 · Received October 12, 2023

    Report

    Report Number
    MW5146929
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    September 14, 2023
    Report Date
    September 30, 2023
    Manufacturer
    ELEVATE ORAL CARE LLC.
    Product Code
    PHR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 MY DENTIST APPLIED SILVER DIAMMINE FLUORIDE TO A TOOTH ON THE UPPER LEFT. SHORTLY AFTER THE PRIMER WAS APPLIED, I HAD INTENSE NERVE PAIN, AFFECTING TOP AND BOTTOM TEETH. THE PAIN CAME AND WENT OVER THE NEXT FEW HOURS, MOVING AROUND. OVER THE NEXT FEW DAYS MY MOUTH WAS SORE IN VARIOUS PLACES WITH INTERMITTENT (AND LESS INTENSE) NERVE PAIN TRIGGERED BY COLD OR FOOD TOUCHING THE TOOTH. THE PAIN SEEMED TO BE SETTLING DOWN BUT I HAD ANOTHER BOUT ON (B)(6). SINCE THEN, THE TOOTH HAS REACTED TO COLD (MORE THAN IT HAD BEFORE THE PRIMER WAS APPLIED) BUT WITH A FEELING MORE LIKE STINGING THAN NERVE PAIN. THE DENTIST CALLED THE COMPANY, WHICH SAID THE PROBLEM COULD HAVE OCCURRED IF THE DECAY REACHED THE NERVE. THAT MAY EXPLAIN THE PAIN OF THE TOP TEETH, BUT DOES NOT SEEM TO APPLY TO THE BOTTOM TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983948 SILVER DIAMMINE FLOURIDE 38% DIAMMINE SILVER FLUORIDE DENTAL HYPERSENSITIVITY VARNISH PHR ELEVATE ORAL CARE LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female