BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JELTRATE

    MDR report key: 594916 · Received April 22, 2005

    Report

    Report Number
    2515379-2005-00106
    Event Type
    Injury
    Date Received
    April 22, 2005
    Date of Event
    March 24, 2005
    Report Date
    March 24, 2005
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT A PATIENT WITH KNOWN ALLERGIES TO SEVERAL SUBSTANCES EXPERIENCED BLISTERING IN THE MOUTH, SWELLING OF THE TONGUE, AND A STICKING FEELING IN THE MOUTH AFTER UPPER AND LOWER IMPRESSIONS WERE TAKEN USING JELTRATE. THE PATIENT TOOK BENADRYL T RELIEVE THE SYMPTOMS, THOUGH NO FURTHER INTERVENTION WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELTRATE ALGINATE IMPRESSION MATERIAL EBH DENTSPLY CAULK NA 0412C73

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention