BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERON APPLICATION CAPSULE

    MDR report key: 8331504 · Received February 12, 2019

    Report

    Report Number
    8010908-2019-00001
    Event Type
    Injury
    Date Received
    February 12, 2019
    Date of Event
    January 28, 2019
    Report Date
    February 12, 2019
    Manufacturer
    VOCO GMBH
    Product Code
    EMA
    PMA / PMN Number
    K130421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE TESTING OF THE MANUFACTURING AND RELEASE DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS. CONTACT WAS MADE WITH THE DENTIST IN CHARGE IN ORDER TO CLARIFY POSSIBLE CAUSES OF THE PROBLEMS. A CLEAR CAUSE COULD NOT BE IDENTIFIED. A PRODUCT DEFECT, AS THE CAUSE OF THE PROBLEMS DESCRIBED, IS NOT IDENTIFIED.

    Description of Event or Problem · 1

    A DENTIST COMPLAINED THAT HE HAD BEEN HAVING PROBLEMS USING MERON APPLICATION CAPSULES SINCE ABOUT 4 WEEKS. IN AT LEAST 15 CASES, PATIENTS COMPLAINED OF PAIN ONE DAY AFTER THE RESTORATION WAS INSERTED. IN AT LEAST 10 CASES AN ENDODONTIC TREATMENT HAD BEEN CARRIED OUT. DETAILS ON THE PATIENTS AND THE INDIVIDUAL TREATMENT PROCEDURES ARE NOT AVAILABLE. VARIOUS CROWNS AND BRIDGES WERE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126630 MERON APPLICATION CAPSULE GLASS IONOMER LUTING CEMENT EMA VOCO GMBH REF 1243 1826554

    Patients

    Seq Age Sex Outcome Treatment
    1 Other