BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTON LIGHT CURE PIT AND FISSURE SEALANT

    MDR report key: 3030606 · Received March 21, 2013

    Report

    Report Number
    2515379-2013-00006
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 27, 2013
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EBC
    PMA / PMN Number
    K831380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE USE OF DELTON, A PRODUCT USED AS A SEALANT. THE SYMPTOMS REPORTED WERE SWELLING OF THE GINGIVA WHICH LASTED FOR TWO WEEKS. NO MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117791 DELTON LIGHT CURE PIT AND FISSURE SEALANT EBC DENTSPLY PROFESSIONAL 120906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other