BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYTIN FC

    MDR report key: 237844 · Received August 27, 1999

    Report

    Report Number
    MW1017060
    Event Type
    Malfunction
    Date Received
    August 27, 1999
    Date of Event
    August 13, 1999
    Report Date
    August 27, 1999
    Manufacturer
    KERR CORP. KERR USA
    Product Code
    EHE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    "DURING THE TRITURATION PROCESS FREE ELEMENTAL MERCURY ESCAPED FROM A CARTRIDGE AND WAS DISBURSED IN MY WORKING ENVIRONMENT. THIS IS A VERY SERIOUS HEALTH HAZARD. THIS INCIDENT COULD LEAD TO MERCURY POISONING. THERE WAS NO PT INVOLVEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYTIN FC CARTRIDGE FOR MIXING EHE KERR CORP. KERR USA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other