AMALGAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-07 for AMALGAM manufactured by Henry Schien.

Event Text Entries

[15219733] I had 12 amalgam fillings. And i was a dental assistant for 24 years. I have full blown mercury poisoning with the test to prove it. Provoked and non provoked after many years of chelation therapy that i had to pay for, because, i was denied workers compensation. They said, i could not provide after mixing amalgam fillings and breathing in the vapors. And getting it on my hands, shoes uniform. That i got it from my job. There are too many people suffering from adverse reactions to mercury from dental offices to keep denying this. Most of them patients. You had (b) (4) adverse reaction reports in 2006, yet (b) (4) told the news there was (b) (4) adverse reports. Dr (b) (4) told me that the (b) (6) people filled out the forms wrong. The forms that we were all told to fill out by the fda, isn't that a coincidence. The truth always comes out. People in wheelchairs, children, mothers, teachers, dentist, dental assistants... It goes on and on. I am so sick i can't stand it anymore. The only thing that keeps me going is that when i got sick i had a (b) (6) baby. Who is (b) (6) now, and still needs me. She has spent her whole life seeing me go from doctor to doctor, spending money my family cant afford looking for help. It's to the point now that i don't know when i will be so sick that i have to stay in bed. Because, i cant afford care, even with two health insurance. Last year, i spent (b) (6) out of pocket on health-care with two insurances and i am not any better than i was before. It is hard for me to sit and type this to you. (b) (6) i really find it hard to believe that you can receive (b) (4) adverse reports in 06 and totally disregard them. Amalgam fillings were placed in my teeth over about 20 years. I worked as a dental assistant breathing in mercury vapors. Having mercury spill on to my hands and rings while trying to put mercury and silver pellets together to mix into amalgam.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5015919
MDR Report Key1686071
Date Received2010-05-07
Date of Report2010-05-07
Date of Event1999-12-02
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 NameAMALGAM
Generic NameAMALGAM
Product CodeEJJ
Date Received2010-05-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerHENRY SCHIEN
Manufacturer AddressLONG ISLAND NY US


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other; 3. Required No Informationntervention 2010-05-07

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