BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETAINER BRITE CLEANING TABLETS

    MDR report key: 7891274 · Received September 19, 2018

    Report

    Report Number
    1036212-2018-00004
    Event Type
    Injury
    Date Received
    September 19, 2018
    Report Date
    November 21, 2018
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    EFT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION HAS BEEN COMPLETED BY THE VENDOR. THE VENDOR FOUND NO ISSUES DURING THE REVIEW OF THE SUSPECT BATCH OR RETAINS. ACCORDING TO THE VENDOR, "OUR TABLETS ROUTINELY UNDERGO RIGOROUS TESTING FOR PHYSICAL, ANALYTICAL, AND SENSORY PROPERTIES, AND CONSISTENTLY MEET AND/OR EXCEED NBE STANDARDS."

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER ORDERED RETAINER BRITE FROM (B)(6) AND UPON OPENING THE PRODUCT, REPORTED A "BLEACHY" SMELL. THE CUSTOMER USED THE PRODUCT CORRECTLY AND REPORTED HIS MOUTH WAS RED AND IT "FELT LIKE A BURN" AFTER USE. THE CUSTOMER DID NOT RELATE THE REACTION TO THE PRODUCT. THE NEXT DAY, THE CUSTOMER USED THE PRODUCT AGAIN AND HAD THE SAME REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730399 RETAINER BRITE CLEANING TABLETS CLEANSER, DENTURE, OVER THE COUNTER EFT DENTSPLY SIRONA ORTHODONTICS INC. NA PN 4494GT

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other