BEUDAMED
    FDA Adverse Event Other Summary report: N

    FUTURABOND U

    MDR report key: 3622155 · Received January 22, 2014

    Report

    Report Number
    8010908-2013-00002
    Event Type
    Other
    Date Received
    January 22, 2014
    Date of Event
    November 1, 2013
    Report Date
    January 21, 2014
    Manufacturer
    VOCO GMBH
    Product Code
    KLE
    PMA / PMN Number
    K130486
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER ANALYSING THE AVAILABLE INFO WE ASSUME THAT THE COMPLAINTS WERE PROVOKED IATROGENICALLY. FUTURABOND U WAS PROBABLY APPLIED IN A LAYER THAT WAS TOO THICK AND/OR DISPENSED BY COMPRESSED AIR TOO INTENSELY. COMPRESSED AIR IS USED TO REMOVE THE SOLVENT. EXCESSIVE USE OF COMPRESSED AIR IS CONTRA-PRODUCTIVE SINCE IT CAN CAUSE A FORMATION OF LACUNAE, TOOTH SURFACE AREAS WITH DISCONTINUOUS COATING AND, ON THE OTHER HAND, THE PRODUCT CAN BE BLOWN INTO THE SULCUS WHERE A LIGHT-CURING POLYMERISATION WOULD BE NO LONGER POSSIBLE OR NOT SUFFICIENT. A CONTACT BETWEEN MUCOSA AND FREE MONOMERS OF THE NON-CURED BONDING CAN CAUSE THE ABOVE MENTIONED PROBLEMS. IN ACCORDANCE WITH THE GENERAL RULES OF THE DENTAL ART, BONDINGS SHOULD BE APPLIED EVENLY IN A THIN LAYER. THE FACT THAT THE PT WAS ABLE TO REMOVE THE MATERIAL WITH A FINGERNAIL INDICATES THAT THE BONDING LAYER WAS FAR TOO THICK. AN OVERLY THICK BONDING LAYER CAN LEAD TO MECHANICAL IRRITATION OF THE GINGIVA OF THE TREATED TOOTH. THE INSTRUCTIONS FOR USE CONTAIN SUFFICIENT INFO TO ENSURE A SAFE APPLICATION OF THE PRODUCT. OUR DEPARTMENT OF KNOWLEDGE COMMUNICATION ESTABLISHED A TELEPHONE CONTACT TO DR (B)(6) AND DISCUSSED POSSIBLE APPLICATION ERRORS. THE CASE WAS ASSIGNED TO THE DEPARTMENT OF RECLAMATIONS AND DOCUMENTED. NO REPORTS HAVE BEEN RECEIVED REGARDING OTHER CASES OF THIS TYPE IN RELATION WITH FUTURABOND U. NO FURTHER MEASURE ARE PLANNED ON THIS MATTER.

    Description of Event or Problem · 1

    THE (B)(4) HAS FORWARDED US A USER REPORT ON ADVERSE EFFECTS DURING THE USE OF ONE OF OUR MEDICAL DEVICES. A PT'S SENSITIVE CERVICAL AREAS WERE TREATED WITH FUTURABOND U (35-37/ UNDERJAW, LEFT SIDE) THE TREATMENT WAS REPEATED AFTER 8 DAYS. AFTER THE TREATMENT, THE PT COMPLAINED ABOUT ACHE AND THROBBING IN THE TOOTH ROOT AREA. THE TOOTH IN QUESTION WAS ONLY AFFECTED BY ONE WEDGE-SHAPED CERVICAL DEFECT AND WAS FREE FROM CARIES OR FILLINGS. ACCORDING TO THE PT, SLIGHT COMPLAINTS STARTED (B)(6), 5 DAYS AFTER THE FIRST TREATMENT AND INTENSIFIED AFTER THE SECOND TREATMENT. THEREFORE, THE PT SCRATCHED OFF THE MATERIAL FROM THE TOOTH WITH A FINGERNAIL, AS A RESULT THE COMPLAINTS STOPPED. NO HEALTH CONSEQUENCES AROSE FROM THIS SITUATION. IN THE MEANTIME, THE DENTIST HAD ANOTHER PT WITH SIMILAR COMPLAINTS. NO FURTHER INFO IS GIVEN ON THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53394 FUTURABOND U ADHESIVE DENTINE KLE VOCO GMBH 1341196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other