BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QMIX 2 IN 1 60ML PACKAGE

    MDR report key: 21919883 · Received April 28, 2025

    Report

    Report Number
    2320721-2025-00067
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Report Date
    April 28, 2025
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    KJJ
    UDI-DI
    D716QMIX60ML1
    PMA / PMN Number
    K103244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A PATIENT HAD A REACTION TO THE QMIX 2 IN 1 60ML PACKAGE. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595970 QMIX 2 IN 1 60ML PACKAGE CLEANSER, ROOT CANAL KJJ TULSA DENTAL PRODUCTS LLC 3270122001668781 D716QMIX60ML1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown