BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M FILTEK SP (ESPE)

    MDR report key: 3233848 · Received July 15, 2013

    Report

    Report Number
    MW5030910
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    November 12, 2012
    Report Date
    July 7, 2013
    Manufacturer
    3M CENTER
    Product Code
    EBF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ILLNESS AND INJURY CAUSED BY A 3M FILTEK SP (ESPE) DENTAL FILLING APPLICATION THAT COMMENCED SHORTLY AFTER THE PROCEDURE ENDED. THE PRODUCT CONTAINS (B)(4). MY ILLNESS AND INJURY INCLUDES BUT IS NOT LIMITED TO SEVERE, NON-VIRAL AND NON-BACTERIAL (NO TEMPERATURE INCREASE), HEAVY PHLEGM THAT CONTINUED FOR MONTHS BEFORE SLOWLY TAPERING OFF. THE MOST SERIOUS INJURY WAS AND REMAINS SHARP SPIKES OF PAIN IN THE SKULL/BRAIN AND EYE SOCKETS. THE SKULL PAIN REMAINS SHARP AND IS SLOWLY TAPERING OFF IN THE NUMBER OF EVENTS MONTHS LATER. AFTER DOING SOME RESEARCH, THE CONCERN WAS AND REMAINS LONG TERM BRAIN DAMAGE INCLUDING ALZHEIMER'S AND CANCER FROM (B)(4) POISONING. REASON FOR USE: DENTAL FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327639 3M FILTEK SP (ESPE) FILTEK EBF 3M CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other