BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUTURABOND M+

    MDR report key: 13024172 · Received December 17, 2021

    Report

    Report Number
    8010908-2021-00009
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    November 1, 2021
    Report Date
    December 17, 2021
    Manufacturer
    VOCO GMBH
    Product Code
    KLE
    PMA / PMN Number
    K141610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FUTURABOND M+ CONTAINS ORGANIC ACIDS, (DI-)METHACRYLATES, AMINES (DABE) AND BHT. INTOLERANCES/ALLERGIES TO THESE INGREDIENTS CANNOT BE EXCLUDED. THE INSTRUCTIONS FOR USE CONTAIN CORRESPONDING WARNINGS. IN GENERAL, FUTURABOND M+ HAS ONLY A VERY LOW ALLERGENIC POTENTIAL WHEN USED CORRECTLY. THE ADHESIVE IS USED IN VERY SMALL QUANTITIES AND SEALED BY THE COMPOSITE FILLING AFTER POLYMERIZATION. IN OUR OPINION, IT IS UNLIKELY THAT THE INCIDENT WAS CAUSED BY FUTURABOND M+. WE ARE NOT AWARE OF ANY SIMILAR CASES RELATED TO FUTURABOND M+. ACCORDING TO OUR INFORMATION, THE DENTIST USED ESTELITE UNIVERSAL FLOW FROM TOKUYAMA DENTAL FOR BONDING THE CERAMIC INLAYS. THIS INDICATION IS NOT COVERED BY THE MANUFACTURER FOR THIS PRODUCT. THE PURELY LIGHT-CURING PRODUCT WILL POSSIBLY NOT POLYMERIZE OR POLYMERIZE INSUFFICIENTLY UNDER A CERAMIC RESTORATION. THIS MAY RESULT IN PROLONGED AND UNDESIRABLE EXPOSURE OF THE PATIENT TO FREE METHACRYLATES AND MAY LEADING TO THE REPORTED PERSISTENT REACTIONS.

    Description of Event or Problem · 0

    ONE PATIENT RECEIVED TREATMENT UNDER GENERAL ANESTHESIA APPROXIMATELY 6 WEEKS AGO. DURING THIS SESSION, TWO SMALL COMPOSITE FILLINGS (11 AND 38) WERE PLACED AND FIVE CERAMIC INLAYS WERE FABRICATED AND CEMENTED IN PLACE. ACCORDING TO THE PATIENT, HE HAS NOT BEEN WELL SINCE THIS TREATMENT. HE HAD A SKIN RASH ALL OVER HIS BODY. THE PATIENT IS CURRENTLY BEING TREATED BY A DERMATOLOGIST. THE PRODUCTS USED HAD BEEN GIVEN TO THE TREATING PHYSICIAN FOR TESTING. WITH FUTURABOND M+, THERE HAD BEEN AN ANOMALY. IT IS NOT KNOWN WHAT THIS ABNORMALITY CONSISTED OF. THE FOLLOWING PRODUCTS WERE USED FOR THE TREATMENT: TETRIC EVO CERAN - IVOCLAR VIVADENT, TETRIC EVO FLOW - IVOCLAR VIVADENT, ESTELITE UNIVERSAL FLOW - TOKUYAMA DENTAL, CEREC INLAYS, FUTURABOND M+ - VOCO GMBH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931662 FUTURABOND M+ FUTURABOND M+ KLE VOCO GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other