MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-08 for DENTAL MERCURY-AMALGAM manufactured by .
[1364497]
(b)(6). In (b)(6) of 1997, i had initial symptoms of polymyositis, a debilitating auto-immune condition. In 1979, (b)(6), i had seven large dental mercury-amalgam fillings placed in my mouth. They were not replaced with 'white' composite fillings until (b)(6) 2007, (b)(6). I also had a number of flu-shots and other vaccine shots, containing thimerosal, between 1997 and 2004. I am now permanently disabled, have been in bed shape for at least 2. 5 years, and believe the constant inflow of mercury into my body, due to amalgams, and subsequent exacerbations due to thimerosal have both caused the polymyositis and have been responsible for further deterioration in my health. Dates of use: #1. 1976-2007; #2. (b)(6) 1997. Diagnosis: #1. Toothache. #2. Preventive tetanus shot. Event abated after use: #1. , #2. No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016687 |
| MDR Report Key | 1757973 |
| Date Received | 2010-07-08 |
| Date of Report | 2010-07-08 |
| Date of Event | 1997-09-17 |
| Date Added to Maude | 2010-07-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTAL MERCURY-AMALGAM |
| Generic Name | MERCURY-AMALGAM OR 'SILVER' FILLINGS |
| Product Code | EJJ |
| Date Received | 2010-07-08 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-07-08 |