BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUTURABOND NR SINGLEDOSE

    MDR report key: 1700288 · Received May 19, 2010

    Report

    Report Number
    8010908-2010-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 18, 2010
    Manufacturer
    VOCO GMBH
    Product Code
    KLE
    PMA / PMN Number
    K053392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL OF ALL PRODUCTS CONTAINING THE FAULTY BATCH OF FUTURABOND NR SINGLEDOSE. NONE OF THE AFFECTED PRODUCT WAS SHIPPED TO THE U.S.!!

    Description of Event or Problem · 1

    A DENTIST COMPLAINED ABOUT A PACKAGE OF OUR BONDING "FUTURABOND NR 200 SINGLE DOSE". THE DISPENSING BAYS CONTAINED NO MATERIAL. DURING APPLICATION THE DENTIST REALIZED THE LACK OF ADHESIVE DUE TO THE LOW LIQUID LEVEL, THE DIFFERENT MIXING BEHAVIOR AND THE ABSENCE OF THE YELLOW SHADE OF THE MATERIAL. FOR THE PATIENT NEITHER SHORT NOR LONG-TERM CONSEQUENCES AROSE FROM THIS INCIDENT. HOWEVER, IT CANNOT BE EXCLUDED THAT OTHER DENTISTS DO NOT REALIZE THE LACK OF ADHESIVE AND APPLY THE MATERIAL AS USUAL. IN THIS CASE THERE IS NO DURABLE BOND BETWEEN FILLING AND TOOTH SUBSTANCE WHICH MAY LEAD TO THE LOSS OF THE FILLING OR A MARGINAL LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUTURABOND NR SINGLEDOSE AGENT, TOOTH BONDING, RESIN KLE VOCO GMBH 1001013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other