BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 16582448 · Received March 21, 2023

    Report

    Report Number
    8010908-2023-00002
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    March 10, 2023
    Report Date
    March 21, 2023
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    PMA / PMN Number
    K080814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE DO NOT HAVE ANY INFORMATION ON THE DENTIST TREATING THE PATIENT, THE PRODUCT VARIANT, THE BATCH, EXPIRY DATE AND DATE OF OCCURRENCE OF THE INCIDENT. OUR INQUIRY REMAINED UNANSWERED. THE AFFECTED PRODUCT WAS NOT SENT IN AND COULD NOT BE CHECKED.THE PATIENT HAS ALLERGIC CONTACT DERMATITIS TO COLOPHONY, PTBPF RESIN, PROPOLIS, MCI/MI, MI, ACRYLATES, BALSAM OF PERU. A MAIN INGREDIENT OF PROFLUORID VARNISH IS COLOPHONY,WHICH IS KNOWN AS BEING POTENTIALLY ALLERGIC. THEREFORE, HER SKIN REACTION CAN BE TRACED BACK TO THIS INGREDIENT. ALL OTHER COMPONENTS ARE NOT INCLUDED IN PROFLUORID VARNISH. ALL POTENTIAL ALLERGIC INGREDIENTS ARE STATED IN THE INSTRUCTION FOR USE AS WELL AS IN THE SAFETY DATA SHEET.

    Description of Event or Problem · 0

    THROUGH A DERMATOLOGIST'S INQUIRY ABOUT THE INGREDIENTS OF VOCO PROFLUORIDE VARNISH, WE HAVE BECOME AWARE OF AN INCIDENT. A 29 YEAR OLD PATIENT DEVELOPED A RASH AFTER BEING TREATED WITH VOCO PROFLUORID VARNISH FOR HER TEETH. SHE USED IT FOR 2 HOURS FOLLOWING HER DENTAL TREATMENT WITHIN 24 HOURS SHE DEVELOPED A WIDESPREAD NETTLE RASH ON HER CHEST, ABDOMEN AND ARMS THAT NEEDED HOSPITAL ADMISSION THE PATIENT IS OK NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7972 VOCO PROFLUORID VARNISH PROFLUORID VARNISH LBH VOCO GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Hospitalization