BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 4917376 · Received July 16, 2015

    Report

    Report Number
    2024312-2015-00018
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 30, 2015
    Manufacturer
    KERR CORPORATION
    Product Code
    MZW
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCTOR ALLEGED THAT FOLLOWING PLACEMENT OF A CROWN USING MAXCEM ELITE A PATIENT EXPERIENCED BLISTERING AND REDNESS AROUND THE GUMS AND ON THE ADJACENT CHEEK AREA. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE DOCTOR WILL MONITOR THE PATIENT'S CONDITION. DESPITE REQUESTS FOR ADDITIONAL INFORMATION, CURRENT PATIENT STATUS IS UNKNOWN. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT(S) WAS NOT RETURNED; THEREFORE, A RETAIN SAMPLE WAS EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DENTAL OFFICE ALLEGED THAT A PATIENT HAD EXPERIENCED BLISTERING AND REDNESS AFTER RESTORATIVE CEMENTATION PROCEDURES WERE COMPLETED USING THE MAXCEM ELITE CLEAR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462811 MAXCEM ELITE CEMENT, DENTAL MZW KERR CORPORATION 5454215

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other PFM CROWN