DENTAL AMALGAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-31 for DENTAL AMALGAM manufactured by Na.

Event Text Entries

[22378977] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5045141
• MDR Report Key: 4975967
• Date Received: 2015-07-31
• Date of Report: 2015-07-31
• Date of Event: 2014-01-18
• Date Added to Maude: 2015-08-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DENTAL AMALGAM
• Generic Name: DENTAL AMALGAM
• Product Code: EKH
• Date Received: 2015-07-31
• Model Number: NA
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NA
• Manufacturer Address: NA NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Deathisabilit	2015-07-31