UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-10 for UNK manufactured by Unk.

Event Text Entries

[1487686] During the (b) (6) 2005, i had 1 amalgam replaced. In (b) (6) of the same year, i had 3 amalgams replaced. In both instances, i used the same dentist who had no assistant; there were no dental dams or suction devices for the mercury vapors caused by the drilling. In (b) (6) 2006, i started feeling abnormally tired and was sleeping a lot, yet felt less and less refreshed. I also just looked old. A few short months later, i found that i was unable to sleep at all and had headaches beyond the severity or type that i had ever felt before. This started to affect my work, and for the first time ever in my life, i started missing work. These symptoms became very severe. I visited my family doctor who ran tests and detected nothing abnormal. I started to have anxiety about it, and visited a psychiatrist who felt my issue was not psychological and said there was nothing else she could do for me. She concluded that i was just burnt out, yet she couldn't say from what. Let me back up first. When my symptoms started, i was a happy and healthy (b) (6) male. I had no history of any medical issues. I had regular physicals every few years and have no family history of any disease or abnormality. Prior to my first symptoms, i had a successful career and was training for a marathon. Over (b) (6) of 2006, my symptoms subsided. I sighed relief and while it was disturbing that i had no idea of the cause, i decided to move on. However, during the spring, my symptoms returned and i again sought out treatment with a naturopath physician who ran tests and noticed that my cortisol was high and my testosterone, and the precursors thereof were low. We continued with a treatment to no avail. During the (b) (6) 2007, my health continued to spiral. My headaches grew worse, i couldn't sleep, my eyes would bulge out of my head from pressure and became discolored, sometimes a deep black or blue. At this time, i sought the help of a well known doctor in the (b) (6) area who was known for her work in chronic fatigue and hormone dysfunction. After several rounds of blood work, my cortisol was extremely low as well as all hormones, with the exception of my thyroid. We continued with bio-identical hormone treatment, yet i did not feel any better. After months of seeing this doctor and many theories that did not pan out, the only conclusion to be found was that i was "somehow toxic. " during this period, i visited many other doctors who all took blood work and all determined that i was toxic somehow. My health spiral continued in 2008, with my hormones continuing to decline despite being on cortisol, testosterone, and dhea. In the spring of 2008, something unusual occurred; 2 lymph nodes in my groin area became inflamed and remained so for at least a month. My family physician ordered a mini biopsy which produced no results. I then had both nodes removed for a full biopsy. Three pathologists could not determine the cause and sent the nodes to (b) (6) which finally determined that the nodes were not cancerous but could not determine the cause. By the summer of 2008, my days consisted of being so sick that i could not do anything but lay on the couch. My brain felt so inflamed and my eyes were so bulged and black that i did not look the same anymore. I could barely take care of myself on a daily basis, let along work. I was now unemployed and incredibly sick. By 2009, i was seeing all types of doctors; allergists, specialists, all kinds, and all came to the conclusion that my hormones were hundreds of a percentage point away from being clinically low, my immune system was stressed, but still no cause could be found. I tested positive for a candida allergy, yet despite many rounds of fluconazole, my candida would recur. In the summer of 2009, i had my first break. I saw a naturopath physician who felt that my symptoms, and the recurrent candida, were the result of mercury toxicity. We ordered a heavy metals test and i came back with 8x's the mercury deemed safe by the cdc or epa, i'm not sure which. Starting in the summer of 2009, i started chelation therapy and felt steady improvement through the fall. Although my symptoms became less severe, i had a recurrence of symptoms and in my despair, revisited my doctor who continued to feel we were on the right path. He explained that the symptoms would ebb and flow from the nature of the mercury storing in the body. However, if i wanted a second opinion, he knew of a mercury lab that were specialists for this sort of thing. In (b) (6) 2009, i visited (b) (6) labs and consulted with (b) (6), owner of the lab. Mr (b) (6) performed a blood, urine, and hair test for mercury. He confirmed the presence of both methyl and inorganic mercury, both a high levels. He also supplied me with samples of the mercury which i brought back to my naturopath doctor who tested the samples on his biomeridian machine. To our suspicions, the machine showed a chronic allergy to methyl mercury and an acute allergy to inorganic mercury. I then continued chelation therapy for mercury and continue to do so. By (b) (6) 2010, chelation proved to be my big break. I had been detoxing specifically for mercury for 7 months. By this time, something amazing happened; all of my hormones returned and my candida was entirely gone. Late (b) (6), things go even better. My whole body seemed to relax. I was able to sleep deeply, and i felt my body shift into relaxation mode. Today, the only time i suffer reactions is when i detox mercury for long periods. The implication here is that when the mercury gets pulled from deep in the tissues, my body reacts to it and i get my symptoms. We suspect that there is a lymphocyte reaction to mercury, and when i get the money for a test, i plan to do so with (b) (6). This website explains that delayed reactions to mercury do occur in people, up regulating the hpa axis causing chronic fatigue over time. This test measures delayed lymphocyte reactions, which would explain why my lymphocytes were reactive and had to be removed. The cause was never found.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5015907
MDR Report Key1686050
Date Received2010-05-10
Date of Report2010-05-10
Date of Event2006-08-01
Date Added to Maude2010-05-17
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 Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameAMALGAM FILLINGS
Product CodeEJJ
Date Received2010-05-10
Lot NumberUNK
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention 2010-05-10

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