BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVICOL

    MDR report key: 25327952 · Received May 29, 2026

    Report

    Report Number
    8010908-2026-00003
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 29, 2026
    Manufacturer
    VOCO GMBH
    Product Code
    EMA
    PMA / PMN Number
    K915618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A DENTIST CLAIMS THAT TREATMENT WITH PROVICOL LED TO LOCALISED, SUPERFICIAL AND, IN SOME CASES, PAINFUL TISSUE CHANGES IN SEVERAL PATIENTS. THE SYMPTOMS DESCRIBED INCLUDE A GREY DISCOLOURATION OF THE GUMS AND, IN SOME CASES, DETACHMENT OF THE MUCOUS MEMBRANE. THERE WAS NO MALFUNCTION. THE RESTORATIONS WERE REPLACED USING AN ALTERNATIVE MATERIAL. THE PATIENTS HAVE MADE A FULL RECOVERY. NO LASTING DAMAGE HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432708 PROVICOL PROVICOL EMA VOCO GMBH 2547165

    Patients

    Seq Age Sex Outcome Treatment
    1