BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY MULTI CURE

    MDR report key: 3131300 · Received May 15, 2013

    Report

    Report Number
    2515379-2013-00019
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBG
    PMA / PMN Number
    K101710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 PT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON 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 IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT PT EXPERIENCED AN ALLERGIC REACTION RESULTING IN A SWOLLEN UPPER LIP IMMEDIATELY AFTER INTEGRITI MULTICURE WAS USED. THE PT WAS TREATED WITH BENADRYL AND THE SWELLING SUBSIDED WITHIN ONE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215779 INTEGRITY MULTI CURE EBG DENTSPLY CAULK 120525

    Patients

    Seq Age Sex Outcome Treatment
    1 Other