BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY MULTI CURE

    MDR report key: 3925375 · Received July 2, 2014

    Report

    Report Number
    2515379-2014-00038
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBG
    PMA / PMN Number
    K101710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    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 AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PATIENT EXPERIENCED SWOLLEN, RED AND PAINFUL GUMS AFTER USING INTEGRITY MULTI-CARE TO FASHION TEMPORARY CROWNS. THE SYMPTOMS BEGAN ONE DAY AFTER PLACING THE TEMPORARY CROWNS. THREE WEEKS LATER THE TEMPORARY CROWNS WERE REMOVED AND THE PERMANENT CROWNS WERE PLACED. AFTER THE PERMANENT CROWS WERE PLACED, THE PATIENT'S SYMPTOMS ABATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385370 INTEGRITY MULTI CURE CROWN AND BRIDGE, TEMPORARY, RESIN EBG DENTSPLY CAULK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TEMP BOND