BEUDAMED
    FDA Adverse Event Other Summary report: N

    FUTURABOND U

    MDR report key: 4003585 · Received August 1, 2014

    Report

    Report Number
    8010908-2014-00001
    Event Type
    Other
    Date Received
    August 1, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 31, 2014
    Manufacturer
    VOCO GMBH
    Product Code
    KLE
    PMA / PMN Number
    K130486
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WE CONSIDER IT UNLIKELY THAT FBU CAUSES THE ABOVE MENTIONED SYMPTOMS WHEN USED PROPERLY. THE CASE WAS ASSIGNED TO THE DEPT OF RECLAMATIONS AND DOCUMENTED. NO REPORTS HAVE BEEN RECEIVED REGARDING OTHER CASES OF THIS TYPE IN RELATION WITH FUTURABOND U. NO FURTHER MEASURES ARE PLANNED ON THIS MATTER.

    Description of Event or Problem · 1

    A DENTIST ALLEGED THAT A PATIENT EXPERIENCED A CHEMICAL BURN ON THE GUM AFTER RECEIVING TREATMENT OF A WORN TOOTH NECK WITH FUTURABOND U AND AN UNK FILLING COMPOSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449487 FUTURABOND U ADHESIVE, DENTINE KLE VOCO GMBH 1418108

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention