BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 4320949 · Received December 11, 2014

    Report

    Report Number
    2024312-2014-00685
    Event Type
    Injury
    Date Received
    December 11, 2014
    Report Date
    November 21, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    MZW
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD FIVE (5) DIFFERENT CROWNS PLACED IN THE LAST FIVE (5) YEARS. IN 2013, DURING THE PATIENT'S LAST VISIT, THE DOCTOR SUGGESTED THAT THE PATIENT SEEK MEDICAL ATTENTION WITH AN ALLERGIST. IT WAS CONFIRMED WITH AN ALLERGIST THAT THE PATIENT IS ALLERGIC TO THE MAXCEM ELITE PRODUCT. THE DOCTOR REPORTED THAT HE WILL REMOVE ALL FIVE (5) RESTORATIONS AND CEMENT THEM WITH ZINC OXIDE EUGENOL BASED CEMENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS ALLEGED IN THIS INCIDENT WERE NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DENTAL OFFICE ALLEGED THAT A PATIENT HAD EXPERIENCED SORES IN THE MOUTH, IRRITATION AND REDNESS ON THE GUM LINE AFTER RESTORATIVE CEMENTATION PROCEDURES WERE COMPLETED USING THE MAXCEM ELITE CLEAR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805826 MAXCEM ELITE CEMENT, DENTAL MZW KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R