BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUJI POWDER

    MDR report key: 395130 · Received May 15, 2002

    Report

    Report Number
    MW1025056
    Event Type
    Death
    Date Received
    May 15, 2002
    Date of Event
    April 20, 2002
    Report Date
    May 6, 2002
    Manufacturer
    *
    Product Code
    EBG
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SIGNIFICANT CHEMICAL ODOR FROM CAPS (18) 5 WEEKS POST CAPS. NECK PAIN RESULTING IN CARDIAC ARREST. NECK SWELLING. INTUBATED AND RESUSCITATED. 2ND CARDIAC ARREST RESULTED IN DEATH. CONSTANT QUESTIONS FROM DR REGARDING CHEMICAL EXPOSURE. (PULMONOLOGIST ON CASE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJI POWDER DENTAL CEMENT EBG * * *
    2 FUJI LINING LIQUID DENTAL CEMENT EBG * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death