BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAN JOY

    MDR report key: 11841317 · Received May 18, 2021

    Report

    Report Number
    8010908-2021-00006
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 18, 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 CARMEL AND VOCO PROFLUORID VARNISH SD PINA COLADA, ONE PATIENT COMPLAINED OF BURNING GUMS AND SWOLLEN LIPS, AS WELL AS A RASH ON HER FACE AND NECK. THE PATIENT ACHIEVED AN IMMEDIATE REDUCTION IN SYMPTOMS BY USING HER OWN EPI PEN IN HOME CARE. THE PATIENT ALSO TOOK 10 MG PREDNISOLONE TWICE. THE NEXT DAY, THE PATIENT WAS SYMPTOM-FREE. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741813 CLEAN JOY CLEAN JOY EJR VOCO GMBH 2017231

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention