BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYCAL

    MDR report key: 13170348 · Received January 5, 2022

    Report

    Report Number
    2515379-2021-00020
    Event Type
    Injury
    Date Received
    January 5, 2022
    Report Date
    January 5, 2022
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EJK
    PMA / PMN Number
    K780384
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. RETAIN PRODUCT WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A REACTION AFTER USING DYCAL DURING A DENTAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133241 DYCAL LINER, CAVITY, CALCIUM HYDROXIDE EJK DENTSPLY CAULK NA 00066863

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other