BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAN JOY

    MDR report key: 11663507 · Received April 14, 2021

    Report

    Report Number
    8010908-2021-00003
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 14, 2021
    Manufacturer
    VOCO GMBH
    Product Code
    EJR
    PMA / PMN Number
    D173566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CLEAN JOY CONTAINS ARTIFICIAL FLAVORS. INTOLERANCES TO THESE INGREDIENTS CANNOT BE RULED OUT IN RARE CASES. THE INSTRUCTIONS FOR USE CONTAIN APPROPRIATE WARNINGS.

    Description of Event or Problem · 1

    AFTER TREATMENT WITH CLEANJOY MINT AND VOCO PROFLUORIDE VARNISH MELON, A PATIENT COMPLAINED OF SWELLING ON HER FACE. THE PATIENT WENT TO THE EMERGENCY ROOM ON THE ADVICE OF THE TREATING DENTIST. THERE WAS NO INPATIENT ADMISSION. TWO DAYS AFTER TREATMENT, THE PATIENT REPORTED AN IMPROVEMENT IN HER CONDITION. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561644 CLEAN JOY CLEAN JOY EJR VOCO GMBH 2038017

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention