BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL CROWN

    MDR report key: 26710 · Received August 28, 1995

    Report

    Report Number
    MW4000762
    Event Type
    Injury
    Date Received
    August 28, 1995
    Date of Event
    July 1, 1993
    Report Date
    July 31, 1995
    Manufacturer
    DAVID MAUK
    Product Code
    ELZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT IS A DENTIST. HUSBAND, WHO IS AN ATHLETE & IN HEALTHY CONDITION, RECEIVED 9 DENTAL CROWNS FROM DR OVER A 6 MONTH PERIOD BETWEEN 7/93 & 9/93. HE IMMEDIATELY STARTED EXPERIENCING SYMPTOMS SUCH AS PARALYSIS, DIZZYNESS, NAUSEA, & FATIGUE, & 5 MONTHS AFTER THE FIRST CROWN WAS RECEIVED "HE COULD NOT FUNCTION". HE WAS DIAGNOSED AS HAVING BRAIN DAMAGE AS WELL. DURING A VISIT TO DR ON 1/13/94 HE HAD A SEIZURE & WAS TREATED AT THE HOSP. ALL THE CROWNS WERE REMOVED 3/95. LAB ANALYSIS OF THE CROWN MATERIAL SHOWED THE CROWNS TO CONTAIN 33 ELEMENTS INCLUDING ARSENIC & MERCURY. COMPLAINANT TALKED TO SEVERAL CROWN MFRS IN THE AREA & WAS TOLD THAT THIS MFR IS KNOWN AS "THE SCRAP METAL MAN". DENTIST APPARENTLY SENDS ALL HIS ORDERS TO THIS MFR, & THE MFR ONLY SUPPLIES THE DENTIST'S PRACTICE. COMPLAINANT HAS NAMES, PHONE NUMBERS, & ADDRESSES OF OTHER PTS OF DR WHO HAVE EXPERIENCED SIMILAR SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTAL CROWN CROWN ELZ DAVID MAUK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization