BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOBAND LIGHT CURE BAND CEMENT

    MDR report key: 4961222 · Received July 29, 2015

    Report

    Report Number
    2418500-2015-00002
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    March 13, 2015
    Manufacturer
    GAC INTERNATIONAL
    Product Code
    DYH
    PMA / PMN Number
    K040375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, SINCE AN INFECTION WOULD LIKELY RESULT IN THE NEED FOR INTERVENTION, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IN THIS EVENT A DENTIST REPORTED THAT THEY WERE HAVING ISSUES WITH NEOBAND CEMENT RUNNING OUT OF THE BAND AND IT WENT INTO THE GUMS OF A PATIENT AND CAUSED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492357 NEOBAND LIGHT CURE BAND CEMENT BRACKET ADHESIVE RESIN DYH GAC INTERNATIONAL 4138-07ID1ABCK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other