BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUTURABOND U SINGLEDOSE 200

    MDR report key: 16774601 · Received April 20, 2023

    Report

    Report Number
    8010908-2023-00003
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 15, 2023
    Report Date
    April 19, 2023
    Manufacturer
    VOCO GMBH
    Product Code
    KLE
    PMA / PMN Number
    K130486
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEFECTIVE MATERIAL PROPERTY WAS DETECTED ON THE RETAINED SAMPLE OF THE BATCH CONCERNED. THE PRODUCT WAS NOT RETURNED TO US. IF USED CORRECTLY, DISCOLORATION OF THE TREATED TEETH IS NOT TO BE EXPECTED. NO SIMILAR INCIDENTS ARE KNOWN. OUR INQUIRIES ABOUT THE CIRCUMSTANCES OF THE TREATMENT WERE NOT ANSWERED.

    Description of Event or Problem · 0

    A DENTIST ALLEGES THAT FUTURABOND U WAS STAINING THE TEETH OF SEVERAL PATIENTS TO A COFFEE BROWN COLOR. IT IS NOT KNOWN IN WHAT WAY AND FOR WHAT INDICATION THE PRODUCT WAS USED. IT IS UNKNOWN IF ANY FOLLOW UP TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157394 FUTURABOND U SINGLEDOSE 200 FUTURABOND U KLE VOCO GMBH 2212546

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other