MAUDE MDR 5616489

MDR report key
5616489
Report number
MW5061964
Event key
0
Event type
3
Date of event
2004-09-01
Date received
2016-04-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MERCURY DENTAL FILLINGMERCURY DENTAL FILLINGEJJ* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-2601. R; 2. S

Event Narratives#

D

Patient 1

IN (B)(6) 2004 BLOODWORK FROM RHEUMATOLOGIST (B)(6) SHOWED THAT I HAD A POSITIVE ANA. THIS STANDS FOR ANTINUCLEAR ANTIBODY AND MEANS THAT THE BODY IS ATTACKING ITSELF AND HAVING AN AUTOIMMUNE REACTION. MY SALIVARY GLANDS HAD STOPPED FUNCTIONING WELL. I TRIED MANY MEDICATIONS THAT GAVE ME NO RELIEF. FINALLY, IN SPRING 2005, I HAD MY MERCURY DENTAL FILLINGS REMOVED BY (B)(6). ONLY AFTER REMOVING MY MERCURY FILLINGS DID I NO LONGER HAVE A POSITIVE ANA FOR BLOODWORK. MY SALIVARY GLANDS REMAIN DAMAGED TO THIS DAY. I HAVE A DIFFICULT TIME SPEAKING FOR AS LONG AS I'D LIKE, AND HAVE TO LIMIT THE AMOUNT OF SPEAKING I DO EACH DAY. I HAVE READ NUMEROUS ARTICLES IN THE (B)(6) LIBRARY SHOWING HOW TOXIC MERCURY IS. I'VE SEEN THE FILMS ON HOW MUCH MERCURY LEAKS FROM MERCURY FILLINGS. SADLY, THESE MERCURY FILLINGS WERE INSTALLED PRIOR TO AGE 18, SO I DONT HAVE ALL THE MANUFACTURERS INFO ON THEM. I DO NOT BELIEVE THAT MY CHILDHOOD DENTIST (B)(6) OF (B)(6) IS STILL IN BUSINESS. WHY WAS THE PERSON USING THE PRODUCT? CAVITIES.