BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENLIGHT

    MDR report key: 4167014 · Received October 13, 2014

    Report

    Report Number
    2016150-2014-00486
    Event Type
    Injury
    Date Received
    October 13, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ORMCO CORPORATION
    Product Code
    DYH
    PMA / PMN Number
    K984217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC INFORMATION WITH REGARD TO THE EXACT NUMBER OF PATIENTS AFFECTED, GENDERS, AGES, AND WEIGHTS WAS NOT PROVIDED. THE DOCTOR REMOVED AND REPLACED THE BRACKETS FOR EACH OF THE PATIENTS. TO DATE, EACH OF THE PATIENTS ARE DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO FURTHER EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT MULTIPLE PATIENTS HAD EXPERIENCED THE ENLIGHT BRACKET BONDING MATERIAL TURNING BROWN AROUND THE EDGES OF THE BRACKETS AND THE SLIGHT DECALCIFICATION OF TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648507 ENLIGHT BRACKET ADHESIVE DYH ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R