BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYTIN

    MDR report key: 4178751 · Received October 16, 2014

    Report

    Report Number
    1815757-2014-00013
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Report Date
    October 2, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    DZS
    PMA / PMN Number
    K935535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED; THEREFORE, A VISUAL AND PHYSICAL EVALUATION WAS PERFORMED ON A RETAIN SAMPLE, YIELDING RESULTS WITHIN SPECIFICATION FOR THE CARVE TIME.

    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 AMALGAM AND REPLACED THE RESTORATIONS FOR EACH OF THE PATIENTS DURING THE SAME PROCEDURE, WITHOUT FURTHER INCIDENT. TO DATE, EACH OF THE PATIENTS ARE DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE TYTIN AMALGAM WAS SETTING UP TOO QUICKLY DURING PROCEDURES FOR MULTIPLE PATIENTS. THIS IS THE SECOND OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658350 TYTIN DENTAL AMALGAM CAPSULE DZS KERR CORPORATION 3-1302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R