AMALGAM DENTAL FILLING

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-15 for AMALGAM DENTAL FILLING manufactured by .

Event Text Entries

[16637244] Amalgam dental filling removal instantly cleared 30 years of persistent and debilitating health issues. I had never had a filling before high school, and eight molars filled with amalgam for surface decay within a 12 month period and then never had another filling again. In my first 2 years of college, i began having debilitating headaches where i would vomit from the pain upon merely standing. I also had episodes where my knees would buckle as if i was about to faint, but i never hit the floor. However, everything in my hands did fall, causing a mess in the cafeteria as i dropped my tray more than once. Doc ordered a blood sugar test to see if it was diabetes. No. With that test and other symptoms along the way, i was diagnosed with hypoglycemia. Hormones were also blamed because symptoms were reliably worse around my cycle. I also had disturbingly blue fingernails often, but reynauds syndrome was ruled out, but checked periodically. Fumbled my way through work and motherhood, always with the headaches, periods of dizziness and depth perception - bumping into furniture, setting glasses on angle, etc-. Symptoms only got worse as perimenopause began. Had heavy metal test due to child's elevated levels. Mine were at (b)(6) being "very elevated. " had half of the fillings replaced with white ones two months ago. Head immediately felt very clear and it continued. Zero blood sugar issues, migraines, dizziness, mental "fog" since day fillings removed. I was at beginning of my cycle on day i had fillings removed and had already experienced 3 days of usual heightened symptoms. Past 10 yrs, symptoms worst at end of cycle. Again, i had no symptoms since day of removal of half of my fillings 2 months ago. Cannot attribute it to anything except having fillings removed. Am scheduled to have rest removed within month. Separately, my son, (b)(6), was overly hyper and agitated in the womb from the first movement and continued this hypersensitivity and activity. Gave him supplements as child to calm and coat nerves. As part of crisis 15 months ago, he had heavy metal test, showing him elevated -7; 8 "very elevated"-, which precipitated my taking the test. He has struggled with this overstimulation, ld issues, impulsitivity his entire life. With movement in womb, exposure likely in utero. From my teeth: how many add/asd children have mothers who had fillings before pregnancy or worked with metals? In our support community, the numbers of families with this exact scenario are to be noted. Other supplemental issues i've had: visual migraines, projectile vomiting with migraines, very cold extremities, blue nails on hands & feet with even slight chill-even in very warm shower, pms, excessive menstrual clotting and excessive high flow, teeth grinding in past, persistent insomnia, very stiff joints, difficulty hearing/functioning in loud places - gyms, etc. -. All these greatly improved in last two months as well. Amalgam dental fillings. All put in between 1979 and 1980. Half removed (b)(6) 2010. Rest scheduled to be removed. Dates of use: 30 yrs. Diagnosis or reason to use: cavity filling. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5018632
MDR Report Key1933934
Date Received2010-12-15
Date of Report2010-12-15
Date Added to Maude2010-12-23
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

Generic NameAMALGAM DENTAL FILLING
Product CodeEJJ
Date Received2010-12-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-12-15

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