AMALGAMS

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 AMALGAMS manufactured by .

Event Text Entries

[1499463] Report an adverse effect to amalgam fillings. On (b) (6) 2008, (b) (6) mom took him to a local chain dentist in (b) (6) county. They placed two amalgams a. K. A. Silver fillings in his right upper and lower molars. Three days later, (b) (6) was ill with a fever of 102 - 102. 9 for 3 days. His fever was accompanied by chills and sweat. Except for the lack of mucus, it appeared as though (b) (6). Had the flu. It turned out that (b) (6). 's fever was a warning sign that something drastic was happening to his body. A few days after his fever broke, (b) (6) woke up with a swollen lip. The swell dissipated after a couple of hours. The next day, it was a swollen jaw, then eyelid. The swelling began on the right side of his face where the new fillings were located. (b) (6) -(b) (6). 's mom- asked the hospital to check for mercury poisoning. Recognizing the correlation, his mom took him to see his primary care doctor. She asked his doctor about the fillings, but her thoughts were quickly dismissed. She was told that silver fillings do not make people sick! (b) (6). 's symptoms continued to escalate. By (b) (6) 2008, he was admitted to the (b) (6) hospital in (b) (6). (b) (6) received 2 units of blood and numerous tests. His mom had researched the amalgams and found that they were primarily mercury, not silver. She found that there was undisputed and admitted evidence that the mercury leaks from the amalgam compound and enters the bloodstream. They tested his blood and did not find an elevated mercury level. No mercury poisoning? What (b) (6) did not know at the time was that a blood test is one of the least efficient ways to test for chronic mercury poisoning. (b) (6) was finally diagnosed with lupus in (b) (6) 2008, stage v nephritis -a kidney disease- in (b) (6) 2009 and by (b) (6) 2009, (b) (6). Was in a wheel chair, diagnosed with neuropathy nerve damage. His symptoms continued to escalate although (b) (6) was on the proper medication. (b) (6). 's mom began researching diligently. What she found shocked her. Amalgams were banned in other countries and (b) (6) had placed restrictions on its use. The u. S. Had never required the mfrs to prove its safety. They were simply grandfathered in. She also found that some people lose the ability to excrete the mercury, so it gets stored in their tissues, causing more harm. (b) (6). 's mercury fillings were safely removed on (b) (6) 2008. (b) (6) photosensitivity to light, rapid heart beat of 135 in sleep, uncontrolled drooling, mouth pain, chest pain and his ignored tremors went away. Although some of his symptoms went away or improved, (b) (6) was still in a wheel chair. The (b) (6) hospital of (b) (6) doctors refused to consider the evidence and research. His mom decided to pack up, try an out of state hospital. Any hospital that would listen! On (b) (6) 2009, (b) (6) was admitted into (b) (6) hospital in (b) (6). The once healthy (b) (6) year old was frail due to losing 30 pounds. He lost that weight even on 60 - 120 mg of steroids a day. For 16 days, (b) (6) tried all their conventional medicines for lupus, nephritis, and neuropathy. They poked, prodded and ran numerous labs. (b) (6) was getting weaker. He couldn't stand, walk, or roll over in bed. (b) (6). Couldn't even wiggle his toes and he was no longer ticklish under his feet. The nerve damage -neuropathy- was worse. They assigned him a physical therapist and an occupational therapist to teach him to cope. (b) (6) mom inundated (b) (6) doctors with research every moment they were in the room. Some wouldn't listen, but she talked anyway. She was sure it was the mercury! On day 16, (b) (6) 2009, the attending physician entered the room and said that (b) (6) hospital would treat (b) (6). For mercury poisoning. (b) (6) hospital had never treated a pt for mercury poisoning due to amalgams, so they had to do a lot of research. (b) (6) mom was told not to expect any results. Chelation therapy for mercury poisoning began that evening and the very next morning, (b) (6) 2009, (b) (6) was able to stand with the aide of a bedside table! Miracle? (b) (6) 2009, (b) (6). Was pushing his wheelchair down the hall. He continued to improve and was released to inpatient physical therapy to strengthen his muscles and walk without assistance again. (b) (6). Dates of use: (b) (6) 2008 - (b) (6) 2009. Diagnosis or reason for use: cavities. Event abated after use: no.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5015894
MDR Report Key1686019
Date Received2010-05-10
Date of Report2010-05-10
Date of Event2008-10-08
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 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

Brand NameAMALGAMS
Generic NameAMALGAMS, SILVER FILLINGS
Product CodeEJJ
Date Received2010-05-10
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit 2010-05-10

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