*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-12-15 for * manufactured by Unk.

Event Text Entries

[146535] Rptr writes: "growing mental and physical exhaustion, disorientation, confusion, inability to carry on with demands of life. Low thyroid diagnosed. Symptoms didn't disappear with medication. Developed many food sensitivities. Lost over 20 lbs. In bed much of the time; very weak. No energy for mental or physical activity. Thought i was losing my mind. Feb '99 consulted another dr who immediately diagnosed problem as heavy metal poisoning confirmed by lab. Mercury from dental fillings. Had all removed from mouth and chelation to remove mercury from body and brain. Still under dr's care but have improved dramatically. " pathologist's discussion states: "this individual's urine mercury is higher than expected but not sufficiently high to assume that symptoms will result directly. Symptomatology can depend on many factors: chemical form of absorbed hg and its transport in body tissues, presence of other synergistic toxics (pb, cd have such effects), presence of disease that depletes or inactivates lymphocytes or is immunosuppressive, organ levels of xenobiotic chemicals and sulfhydryl-bearing metabolites (e. G. , glutathione), and the concentration of protective nutrients, (e. G. , zinc, selenium, vitamin e). Early signs of mercury contamination include: decreased senses of touch, hearing, vision and taste, metallic taste in mouth, fatigue or lack of physical endurance, and increased salivation. Symptoms may progress with moderate or chronic exposure to include: anorexia, numbness and parathesias, headaches, hypertension, irritability and excitability, and immune suppression, possibly immune dysregulation. Advanced disease processes from mercury toxicity include: tremors and incoordination, anemia, psychoses, manic behaviors, possibly autoimmune disorders, renal dysfunction or failure. Note that in mercury contamination of long duration, renal excretion of mercury (and normal metabolites) may become impaired, and the urine level of mercury might be only mildly elevated or not elevated at all due to renal failure. Mercury is commonly used in: dental amalgams, explosive detonators; in pure liquid form for thermometers, barometers, and laboratory equipment; batteries and electrodes ("calomel"); and in fungicides and pesticides and in the paper industry. The fungicide/pesticide use of mercury has declined due to environmental concerns, but mercury residues persist from past use. Methylmercury, the common, poisonous form, occurs by methylation in aquatic biota or sediments (both fresh water and ocean sediments). Methylmercury accumulates in aquatic animals and fish and is concentrated up the food chain reaching high concentrations in large fish and predatory birds. Except for fish, the human intake of dietary mercury is negligible unless the food is contaminated with one of the previously listed forms/sources. A daily diet of fish can cause 1 to 10 micrograms of mercury/day to be ingested, with about three-quarters of this (typically) as methylmercury. Depending upon body burden and upon type, duration and dosage of detoxifying agents, elevated urine mercury may occur after administration of: dmps, dmsa, d-penicillamine or edta. Elemental analysis of hair can be a corroborating test for mercury burden. Blood and especially blood cell analyses are only useful for diagnosing very recent or ongoing organic (methyl) mercury exposure. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1017731
MDR Report Key254933
Date Received1999-12-15
Date of Report1999-12-10
Date of Event1997-01-01
Date Added to Maude1999-12-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameMERCURY DENTAL FILLINGS
Product CodeELY
Date Received1999-12-15
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key246861
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention; 3. Deathisabilit 1999-12-15

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