BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYCAL RADIOPAQUE CALCIUM HYDROXIDE COMPOSITION

    MDR report key: 9205359 · Received October 17, 2019

    Report

    Report Number
    2515379-2019-00030
    Event Type
    Injury
    Date Received
    October 17, 2019
    Report Date
    January 15, 2020
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EJK
    PMA / PMN Number
    K780384
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE MEDICAL/SURGICAL INTERVENTION WAS REQUIRED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ADVERSE REACTION AFTER UNDERGOING A ROUTINE RESTORATIVE PROCEDURE WITH DYCAL AS ONE OF THE COMPONENTS. AN INDIRECT PULP CAPPING PROCEDURE WAS PERFORMED, AND THE TOOTH EVENTUALLY NEEDED ENDODONTIC TREATMENT. THE DENTIST CLAIMS THAT ENDODONTIC THERAPY HAD TO BE PERFORMED DUE TO THE MALFUNCTION OF THE DYCAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999640 DYCAL RADIOPAQUE CALCIUM HYDROXIDE COMPOSITION LINER, CAVITY, CALCIUM HYDROXIDE EJK DENTSPLY CAULK NA 171201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention