BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYTIN

    MDR report key: 2421579 · Received January 19, 2012

    Report

    Report Number
    1815757-2012-00001
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 26, 2011
    Manufacturer
    KERR CORPORATION
    Product Code
    DZS
    PMA / PMN Number
    K935535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY WAS ASSOCIATED WITH THIS INCIDENT BUT ONE MDR IS BEING SUBMITTED BECAUSE IF THIS MALFUNCTION WERE TO RECUR IT MAY LEAD TO INHALATION OF THE UNMIXED PARTICLES BY THE DOCTOR OR PATIENT. NO PRODUCT WAS RETURNED; AN EVALUATION ON THE RETAIN SAMPLE WAS PERFORMED AND FOUND TO MEET PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER STATED THAT AFTER MIXING A TYTIN CAPSULE IN AN AMALGAMATOR AND OPENING IT UP, THE MERCURY WAS NOT MIXED WITH THE SILVER POWDER. THE CONTENTS SPILLED OUT OVER THE OPERATION AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYTIN DENTAL AMALGAM CAPSULE DZS KERR CORPORATION 0-1238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other