BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYCAL

    MDR report key: 473818 · Received July 25, 2003

    Report

    Report Number
    2515379-2003-00084
    Event Type
    Injury
    Date Received
    July 25, 2003
    Date of Event
    May 8, 2003
    Report Date
    June 26, 2003
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED A PT EXPERIENCED EDEMA, ORAL AND LABIAL MUCOSA INFLAMMATION AND NECROTIC ULCER THAT LASTED FOR 15 DAYS, AFTER USING A UNIT OF CATALYST PASTE. THE PRODUCT WAS REMOVED AND ANOTHER CATALYST FROM THE SAME BATCH WAS USED WITHOUT INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other