MERCURY AMALGAMS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-20 for MERCURY AMALGAMS manufactured by .

Event Text Entries

[1734468] I am writing with regard to your concern about the use of mercury amalgams in dental fillings. My life was virtually destroyed about twenty years ago after i went to a dentist in (b)(6) for filling. The dentist packed amalgams next to an exposed nerve. The left side of my face became numb about two weeks later and i went to a physician and asked him if i was having a stroke. He said it looked more like a brain tumor and scheduled me for an mri at (b)(6) hospital in (b)(6). The mri was done and a physician said i had multiple sclerosis because my myelin sheath was disappearing on my spine and i had lesions in my brain. I had a lumbar puncture and no definite diagnosis could be made. I have no relatives with ms and the small community where i lived was in shock at what had happened to me. I had a degree in physics, had introduced drip irrigation to the high plains area, and was working on perfecting a patented trenching machine i had invented when this happened. Then i was lying in bed very ill, lost my speech, i could not walk a straight line and staggered as if i were a drunk from off skid row! The community held a meeting to help me. One lady told how she was suffering from lupus and went to a (b)(6) clinic in (b)(6) and they helped her. Another lady was a dental hygienist and said she had heard of people reacting to amalgam fillings. Another lady told of a physician in (b)(6) that had had marvelous results from his practice. I called the clinic in (b)(6) and told them i was diagnosed with ms. I traveled to (b)(6) and within a few hours, the doctor came in and i asked him, "am i shorted out? " he repled, "you don't have ms. You are sensitive to heavy metals--such as lead and mercury! " i had been using lead based paint for my machines and thought i had lead poisoning from the paint. I chose chelation to rid myself of the lead. After the first blood sample was analyzed, the company wrote back and stated, "we thought we had made a mistake. We ran tests three times and your cholesterol is under 20, combined. " my father had low cholesterol and i, too, have low cholesterol. I was slow to realize that the heavy metal was not lead, but was "in my head. " i went back to the dentist and asked him if he would remove the filling he had put in. He said, "you'll have to get back in line. " because he didn't treat this as an emergency, i told people about his reaction and within a few weeks his new house was for sale and he was moving to (b)(6). A person spoke in church and said he was a dentist from (b)(6). After he spoke, i told him of my problem and asked if he could help me. Within two weeks, he had the fillings replaced with composites. My recovery was not immediate, but i began to put on weight and looked healthier. I moved to (b)(6) and found a new dentist. His clinic had just received a new x-ray machine and he found a piece of amalgam down in my jaw where a molar had been removed. A periodontist removed the amalgam and i asked her how far down it was and she repled, "about a quarter inch. I wonder how it got down there? " i had had swelling in my lymph nodes and went to an internal medicine physician and asked him about it. He said he didn't know what was causing the lymph nodes to swell. The swelling was due to "an allergy to amalgams! " i still struggle with the effects of the amalgams. I hope and pray you will seriously consider how poisonous these things can be to some people! I beg of you to not allow mercury amalgams in dental practice.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5019128
MDR Report Key1972640
Date Received2011-01-20
Date of Report2011-01-20
Date Added to Maude2011-02-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMERCURY AMALGAMS
Generic NameMERCURY AMALGAMS
Product CodeDZS
Date Received2011-01-20
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2011-01-20

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