BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 8073068 · Received November 15, 2018

    Report

    Report Number
    8010908-2018-00001
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    September 4, 2018
    Report Date
    November 15, 2018
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    PMA / PMN Number
    K080814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE PRODUCT IN QUESTION COULD NOT BE PERFORMED. THE PRODUCT WAS NOT RETURNED TO US. LOT-NUMBER AND EXPIRY DATE ARE UNKNOWN. THE CASE WAS ASSIGNED TO THE DEPARTMENT OF COMPLAINTS AND DOCUMENTED. NO FURTHER MEASURES ARE PLANNED ON THIS CASE. COLOPHONY-INTOLERANCES CANNOT BE EXCLUDED, ESPECIALLY FOLLOWING APPLICATION TO EXTENSIVE SURFACES LIKE THIS CASE. THE INSTRUCTIONS FOR USE CONTAIN APPROPRIATE WARNINGS.

    Description of Event or Problem · 1

    (B)(6) FORWARDED TO US A REPORT FROM A HEALTHCARE PROVIDER REGARDING AN INCIDENT WITH VOCO PROFLUORID VARNISH. THE INCIDENT CONCERNS A PATIENT WITH SIDE EFFECTS AFTER TREATMENT WITH PROFLOURID VARNISH. VOCO PROFLUORID VARNISH IS MARKETED IN US. THEREFORE, THE EVENT IS REPORTABLE ACCORDINGLY 21CFR 803. INCIDENT DESCRIPTION WE RECEIVED FROM DENTIST: "REACTION DESCRIPTION: THE PATIENT HAD NOT BEEN GIVEN A LOCAL ANAESTHETIC AND NO DENTAL REASON COULD BE FOUND FOR THE ALLERGIC REACTION. THE NUMBNESS AND SWELLING WERE SUBSIDING THE NEXT DAY, BUT I ADVISED HIM TO SEE HIS DOCTOR AS I COULD NOT PRESCRIBE AN ANTIHISTAMINE. HE MENTIONED THAT HE WAS ALLERGIC TO SEAFOOD AND HAS A SORT OF SIMILAR REACTION TO SEAFOOD. MEDICALLY SIGNIFICANT DETAILS: PROFLUORID VARNISH WAS APPLIED TOPICALLY TO TWO TEETH AT UL56 FOR SENSITIVITY. PATIENT RETURNED THE NEXT DAY WITH A SWOLLEN CHEEK AND LIP AND NUMBNESS OF THE LEFT SIDE OF HIS FACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915267 VOCO PROFLUORID VARNISH VOCO PROFLUORID VARNISH LBH VOCO GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other