BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY MULTI CURE

    MDR report key: 3170072 · Received June 4, 2013

    Report

    Report Number
    2515379-2013-00027
    Event Type
    Injury
    Date Received
    June 4, 2013
    Report Date
    May 10, 2013
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBG
    PMA / PMN Number
    K101710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK 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 EVAL. 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 THE PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER COMING IN CONTACT WITH INTEGRITY MULTI-CURE. THE PATIENT'S LIPS SWELLED SOON AFTER USE. THE PATIENT WAS ADMINISTERED BENADRYL AND THE SYMPTOMS SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247804 INTEGRITY MULTI CURE EBG DENTSPLY CAULK 120103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other