MAUDE MDR 4975967

MDR report key
4975967
Report number
MW5045141
Event key
0
Event type
3
Date of event
2014-01-18
Date received
2015-07-31
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
306
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
1DENTAL AMALGAMDENTAL AMALGAMNAEKHNA* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-3101. D; 2. S

Event Narratives#

D

Patient 1

I AM SUBMITTING THIS REPORT POSTHUMOUSLY FOR MY MOTHER, (B)(6). SHE HAD ORAL AND PHYSICAL HEALTH PROBLEMS OVER THE YEARS THAT SEEMED RELATED TO THE FILLINGS SHE HAD EVER SINCE SHE WAS YOUNG. SHE DEVELOPED SUPER SENSITIVE TEETH AND BURSITIS, WHICH INTERFERED WITH HER WORK, TEACHING DANCE CLASSES AND RUNNING A HOUSECLEANING BUSINESS. SHE WAS UNABLE TO PAY FOR REMOVAL AND REPLACEMENT OF AMALGAM FILLINGS IN HER REMAINING MOLARS, ALREADY HAD 3 TEETH PULLED, AND HAD LARGE CROWNS MADE OF AMALGAM. HER MOUTH HURT ALL THE TIME, WITH EATING AND DRINKING, BRUSHING, EVEN WHEN JUST BREATHING. ON (B)(6) 2014, SHE WROTE A LETTER TO (B)(6) ASKING FOR HELP, AND FOR A SURGEON GENERAL'S REPORT TO GET TO THE BOTTOM OF THE HEALTH IMPACTS OF MERCURY DENTAL AMALGAM. SHE CC'D (B)(6). HER BROTHER WROTE A SIMILAR LETTER. TWO DAYS LATER, SHE DIED UNEXPECTEDLY. THERE MAY HAVE BEEN MULTIPLE CAUSES, BUT THE IMPACT OF A LIFETIME OF MERCURY IN HER BODY AND ON HER HEART DID HER NO FAVORS. REGARDING HER LETTER, NOBODY EVER CALLED TO FOLLOW UP. WE GOT AN EMAIL CONDOLENCE FROM (B)(6). (B)(6) WAS THE EXCEPTION. HE WAS A FAMILY FRIEND, IS A (B)(6), AND HANDLED HER FUNERAL.