BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYTIN

    MDR report key: 3736182 · Received April 9, 2014

    Report

    Report Number
    1815757-2014-00004
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Report Date
    March 10, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    DZS
    PMA / PMN Number
    K935535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC INFORMATION WITH REGARD TO PATIENT GENDER, AGE, AND WEIGHT WERE NOT PROVIDED. THE DOCTOR REMOVED THE AMALGAM AND REPEATED THE PROCEDURE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED; THEREFORE, A PHYSICAL EVALUATION WAS PERFORMED ON A RETAINED SAMPLE OF THE PRODUCT, YIELDING RESULTS WITHIN SPECIFICATION FOR CARVE TIME.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE TYTIN AMALGAM WAS TOO GRAINY AND HARD TO CONDENSE DURING PROCEDURES FOR THREE (3) PATIENTS. THIS IS THE THIRD OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214536 TYTIN DENTAL AMALGAM CAPSULE DZS KERR CORPORATION 3-1221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R