BEUDAMED
    FDA Adverse Event Other Summary report: N

    DENTAL CROWN

    MDR report key: 1933945 · Received December 10, 2010

    Report

    Report Number
    MW5018633
    Event Type
    Other
    Date Received
    December 10, 2010
    Date of Event
    February 16, 2010
    Report Date
    December 10, 2010
    Manufacturer
    3 M COMPANY
    Product Code
    ELZ
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A DENTAL FILLING AND CROWNS. STEEL CROWN DONE ON PRIMARY TEETH. COUPLE MONTHS LATER PT STARTED EXPERIENCING SEIZURES. SEIZURES FIRST STARTED AS "JERKING" THEN GRAND MAL SEIZURE. MOM TOOK PT TO NEUROLOGIST. ANTI SEIZURES MEDICATION WAS PRESCRIBED BUT SEIZURES STILL PERSIST. MOM TOOK PT TO ANOTHER PEDODONTIST AND HAD THE CROWN REMOVED. AFTER CROWN WAS REMOVED THE SEIZURES STOPPED. PT'S MOM WANTS WARNING LABEL ON CROWNS, AND DENTAL FILLING MATERIAL OF POSSIBLE RISK ETC SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTAL CROWN ELZ 3 M COMPANY
    2 DENTAL FILLING MATERIAL EJJ 3 M COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR