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 2014-11-11 for DENTAL AMALGAM manufactured by .

Event Text Entries

[5227203] I had six amalgam fillings in temporary teeth and 13 by age 18 in my adult teeth. They were removed and replaced with new formula amalgam in 1987. I suffered my first migraines and cluster headaches following this. I had my first high blood pressure readings (140-145/85-95) at age 35. I was a strong (b)(6) 6' male and could barely walk up one flight of stairs. I was cold all the time. The skin peeled off my feet and hands and they were pink. That is classic acute mercury poisoning seen with infant teething powders. Complaints of these sudden changes got me labeled as a hypochondriac by my gp and i did not know enough to find one who would listen. These health issues lowered my job performance and i lost my academic career. I had a tooth break because of the amalgam filling in 1999, and the dentist placed one to the gum line. This improper use meant mercury went directly into my bloodstream. My vision and memory and job performance suffered. My bp skyrocketed (189/121) at age (b)(6). In a year i had a severe angina attack with hospitalization, followed by two more. Heart catheters and ultrasound/exercise/dye treatments show no blockage. It is now known that mercury and lead can do this. They are synergistic. I had ra-like, ms+like, and fm-like symptoms. I had bruxism and eight of the remaining 11 amalgam fillings were the largest the dentist had seen in 5 years. So my exposure to mercury was well beyond epa or fda "safe" levels. The weird symptoms all cleared with the removal of my amalgams. My angina has not reappeared. My bp is under control with one instead of four meds. The migraines and cluster headaches are gone. I don't fall over or walk into door jams. The tinnitus is improved. Vision is much better. Memory still needs work, but is much improved. I can stand being in crowds and social contact is much easier. I can understand conversations and my math and problem solving abilities are largely returned.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5039092
MDR Report Key4265276
Date Received2014-11-11
Date of Report2014-11-11
Date Added to Maude2014-11-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
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 CodeEKH
Date Received2014-11-11
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit 2014-11-11

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