DENTAL AMALGAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-22 for DENTAL AMALGAM manufactured by Unk.

Event Text Entries

[1627688] Heavy metal intoxication resulting from dental amalgam exposure. In 2004, i received 20+ amalgams in 12 teeth. Prior to this i had only had 1 amalgam my entire life. I was not made aware at the time that amalgams contain mercury or that any controversy surrounded their use. At the time of placement i was in exquisite health. I was a black belt martial artist and instructor. I could run 10 miles without preparation at a 7 min. Pace. In 2005, i had a very uncharacteristic incidence of respiratory and throat infection. In 2006, i began experiencing ambiguous health decline. My first symptoms were fatigue and neuropathy/neuralgia. I had tingling sensations and numbness in my face and down my neck and arm. I sought medical attention to rule out stroke. I was tested for lyme disease which returned negative and referred to a neurologist for further examination. The neurologist ruled out stroke and said i could have a pinched nerve. Symptoms remained tolerable though progressive. I began compensating for symptoms or explaining them away. By 2008, they had progress to a persistent and undeniable level. Having no clue what was happening to me i began seeking medical attention for diagnosis of what seemed to be a "mystery disease". Over 2008 and 2009 i saw several drs and specialists to no avail. I was given a diagnosis of lyme disease, though i never produced a cdc positive lyme test. My treatment for lyme disease resulted in no reduction of core symptoms after 8+ months. Finally in 2010, it was proposed that my precipitous decline in health over 6 years that ultimately resulted in my inability to work a full time job was the result of mercury intoxication from my extensive amalgam placements. A clinical diagnosis was made based on years of lab data and clinical symptoms. In my opinion confirmation of this diagnosis is affirmative based on the substantial intensification of symptoms resulting from chelation agents. Were the mercury accumulation immaterial, chelation agents would not illicit definitive, reproducible, amplification of existing and persistent symptoms. Please find a comprehensive list of my symptoms and timeline: neurological/cognitive: fatigue, progressive/persistent, 3 years, reduced concentration, periodic, 2 years. Blurred vision, periodic, 2 years. Reduced memory. Periodic, 2 years reduced concentration, subtle, 2 years, neuropathy, subtle, 1 year. Vertigo, occasional, 3 years. Numbness/tingling-left, periodic, 4 years, side of face, down neck. Psychological: anxiety, periodic, 3 years. Apathy, persistent, 1 year. Depression, periodic, 1 year. Gi: digestive problems, periodic, 5 years. Constipation, periodic, 5 years. Diarrhea, occasional, 5 years. Gluten intolerance, persistent, 3 years. Abdominal pains/cramps, periodic, 5 years. Muscular: muscle cramps-primarily legs, subtle/persistent, 1 year. Muscle loss and weakness, persistent, 2 years. Tremor/twitch, periodic, 2 years -hands, feet, eyes. Joint pain-mandible, persistent, 4 years neck, left shoulder -arthritis symptoms w/o apparent inflammation -most joints- 2 years. Vascular: untreated bp -140/90, persistent, 4 years. Tachycardia, periodic, 3 years. Palpitations -with exercise- occasional, 3 years. Other misc symptoms/abnormalities: sinusitis, periodic, 4 years. Tinnitus -buzzing in left ear -periodic, 4 years. White cell count below 4, persistent, 3 years. Low nk cell count, slightly elevated liver enzymes, periodic, unk. Low blood creatinine. Low platelets, low body temp -97 degrees- persistent, 3 years. Weight loss, persistent, 2 years -(b)(6) despite 2000+ cal diet and reduced activity. Frequent urination, persistent, 3 years. Itchy skin, periodic, 2 years. Low ceruloplasmin, unk. Low serum copper, unk. Low free copper urine. Dose or amount: 20+, frequency: in one month, route: po. Dates of use: 6 years. Diagnosis or reason for use: to fill cavities.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5016863
MDR Report Key1781619
Date Received2010-07-22
Date of Report2010-07-22
Date of Event2010-07-21
Date Added to Maude2010-08-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDENTAL AMALGAM
Generic NameDENTAL AMALGAM
Product CodeEJJ
Date Received2010-07-22
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2010-07-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.