BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY

    MDR report key: 2103736 · Received May 17, 2011

    Report

    Report Number
    2515379-2011-00009
    Event Type
    Injury
    Date Received
    May 17, 2011
    Report Date
    April 21, 2011
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBG
    PMA / PMN Number
    K924830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS NOT DEFINITIVELY KNOWN IF THE INTEGRITY USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'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 IS REPORTABLE PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT THE DAY FOLLOWING PLACEMENT OF A PROVISIONAL RESTORATION USING INTEGRITY, A PT EXPERIENCED SWELLING OF THE LIP AND GINGIVA AND PRESENCE OF MUCOUS ON THE RESTORATION. THE DR ADVISED USE OF BENADRYL AND A TOPICAL CREAM AS A RESULT. WHEN THE RESTORATION WAS REMOVED, THE SYMPTOMS REPORTEDLY LESSENED; THE SYMPTOMS INTENSIFIED WHEN THE RESTORATION WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY EBG DENTSPLY CAULK 0805029

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention