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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-03 for * manufactured by *.

Event Text Entries

[19771436] The first dr pt was referred to for mercury treatment, did not test correctly or administer dmsa correctly, in pt's opinion. He prescribed chemet and had pt do urine collection on the third day. Pt has subsequently read, in many resouces, that you should collect it on the first day. So the pt never knew what pt's initial memory levels were. It is extremely difficult to find a dr to treat mercury poisoning. It took several months of research for pt to find dr to treat mercury poisoning. It took several mos of research for pt to find dr who has had to not only treat the mercury poisoning but also repair the damage done to pt's immune system by the overdoses of chemet they experienced under first dr. The first problem with mercury poisonoing is getting it diagnosed. Unfortunately, few, if any primary care physicians are trained to recognize the symptoms. Pt's primary care physician thought of it after about 3 months of tests. The only reason he thought of it was because a symptom pt mentioned - an icy sensation in neck and extremities - triggered a memory of a conversation he overheard by a co-worker who had been poisoned and then treated. It was only after doing research about mercury poisoning and its causes that pt rememebered breaking a mercury thermometer shortly after thanksgiving, 2003. Symptoms - brain fog, swelling and pain in neck, arms, legs and ankles, icy sensation, total lack of energy, inability to sleep without drugs, rapid heart beat, chest pain, and breathlessnes, swelling in lymph glands - were consistent with that diagnosis. It was suggested that pt have amalgam dental fillings removed. Until this time, pt had no plans for dental work this year beyond annual cleaning. Pt thought their mouth was the least of their problems. However, pt soon found out by medical opinion and research, that you need to remove mercury from your mouth for several reasons. For one thing, those amalgam fillings are leaking mercury into system at all times. Furthermore, the mercury they are leaking can be moved into brain and organs even further by chelation treatments. Unfortunately, due to bad advice and pt's ignorance pt had several fillings removed without any protection from further mercury exposure prior to seeing dr. This dental work that was done in february, during which pt was unprotected, caused pt to experience more mercury poisoning from vapor and pt became even more ill. Anyone who treats you for mercury poisoning will rightly insist on removing this toxic element from your mouth. By the time pt saw dr, pt was severely mercury poisoned and he immediately prescribed a round by chemet. Based on his experience, he made the diagnosis by symptom eval and prescribed this drug to get pt some releif quickly. Pt was told that they would have many rounds of chemet pt had some reduction of symptoms but felt that the chemet had been over-prescribed - dangerously so and that case was not being handled well. Pt had taken 4500 mg of chemet over a period of three days which pt now believes is a huge overdose. After some research, pt found dr. She is an m. D. That has additional certification in alternative medicine. She referred pt to a dentist who could more safely remove the amalgam fillings and she had been treating pt for all the associated biochemistry disruption that occurs with mercury poisoning. It disrupts neurotransmitter and hormone functioning among other problems. Pt has to take ambien to sleep - otherwise they lie awake all night - and xanax to reduce the rapid heart beat and breathless feelings. In addition, she suggested supplements to support amino acids and neurotransmitters to correct the damage done, improve body function and help body's natural chelation process. Pt took a reduced amount of chemet a third time in 6/20004, around the time of some additional dental work. Pt now believes the first two dangerously high levels of chemet combined with this third round and all the exposure from the various dental procedures had severely damaged their imnune system. Pt's energy level, which had been low, was so compromised that they did not have enough stamina to work 8 hours a day. Between june and september, 2004, pt had five rounds of antibiotics and much dental work to overcome infection. Contacted dr who said to stop the amalgam removal, for now, as immune system was too compromised. She prescribed vitamin infusions twice weekly - vitamin c, magnesium and b complex - in an effort to restore immune system. In addition, pt had their gall bladder removed 12/22. It was fine prior to the merucry poisoning. Pt's believes that due to the extremely high load of mercury toxicity pt had and the dangerous levels of chemet that they were prescribed, that the gall bladder was damaged. Dr. 's recommedations and treatment have helped immensely. The chemet reduced the brain fog, so that pt could function at work.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1034296
MDR Report Key566035
Date Received2005-01-03
Date of Report2005-01-03
Date of Event2004-12-05
Date Added to Maude2005-01-19
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 FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNA
Generic NameMERCURY THERMOMETER
Product CodeFLK
Date Received2005-01-03
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key555821
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2005-01-03

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