BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAULK TRAY ADHESIVE REFILL

    MDR report key: 17821432 · Received September 26, 2023

    Report

    Report Number
    2515379-2023-00101
    Event Type
    Injury
    Date Received
    September 26, 2023
    Report Date
    December 28, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELW
    UDI-DI
    D0026261550
    PMA / PMN Number
    K781151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION TYPE: RETAIN, PASS; INVESTIGATION TYPE: DHR, DHR'S WITHIN SPECIFICATION. 626155, LOT#: 00089107, FG; 926156, LOT#: 00085195, FILLED; 926109, LOT#: 00084243, BULK. FAILURE MODE: POSSIBLE ALLERGIC REACTION; ROOT CAUSE: NOT DETERMINED; CONCLUSION CODE: INDETERMINABLE.

    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 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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORT THAT A PATIENT EXPERIENCED AN ADVERSE REACTION AFTER UNDERGOING A DENTAL PROCEDURE THAT CAULK TRAY ADHESIVE WAS USED. REPORTEDLY, PATIENT PRESENTED WITH MILD RESPIRATORY DIFFICULTY. PATIENT DOES HAVE KNOWN ALLERGIES TO LATEX AND CERTAIN TYPE OF FISH. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832241 CAULK TRAY ADHESIVE REFILL MATERIAL, IMPRESSION ELW DENTSPLY LLC 85195 D0026261550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown