BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYCAL

    MDR report key: 2550648 · Received April 20, 2012

    Report

    Report Number
    2515379-2012-00007
    Event Type
    Injury
    Date Received
    April 20, 2012
    Report Date
    March 23, 2012
    Manufacturer
    DENTSPLY DETREY
    Product Code
    EJK
    PMA / PMN Number
    K780384
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DYCAL 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 MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT SEVERAL DAYS AFTER PLACEMENT OF THREE PROVISIONAL CROWNS DURING A PROCEDURE IN WHICH DYCAL WAS ALSO PLACED, THE PT RETURNED TO THE OFFICE WITH DISCOMFORT, REDNESS AND PAIN IN THE ASSOCIATED AREA AND SLIGHT SWELLING OF THE FACE. THERE IS NO INDICATION THAT INTERVENTION WAS REQUIRED TO TREAT THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYCAL EJK DENTSPLY DETREY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other