BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULITE ULTRA

    MDR report key: 4090001 · Received September 15, 2014

    Report

    Report Number
    2024312-2014-00615
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    September 5, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K082671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC INFORMATION WITH REGARD TO THE EXACT NUMBER OF PATIENTS AFFECTED, GENDERS, AGES, AND WEIGHTS WERE NOT PROVIDED. THE DOCTOR REMOVED THE COMPOSITE AND REPLACED THE RESTORATIONS EACH OF THE PATIENTS UPON THEIR RETURN TO THE OFFICE. TO DATE, EACH OF THE PATIENTS ARE DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, A VISUAL AND PHYSICAL EVALUATION WAS PERFORMED ON A RETAINED SAMPLE FROM THE SAME LOT, YIELDING RESULTS WITHIN SPECIFICATIONS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT THE CONSISTENCY OF THE HERCULITE ULTRA HAD BEEN TOO DRY AND HARD DURING PROCEDURES ON MULTIPLE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569656 HERCULITE ULTRA MATERIAL, TOOTH SHADE, RESIN EBF KERR CORPORATION 5176657

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R