MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-08 for AMALGAM MERCURY FILLINGS manufactured by Unk.
[47111688]
Received mercury amalgam in 1990 and 1998. (4 fillings). I received 4 mercury fillings, and two refurbished mercury fillings in 1998. After my fillings, i noticed mouth always taste like metal. Mercury fillings has been declared toxic in 2014 federal court. Hippa records do not have the early 90's records of my mercury procedures but will take xray. Chips of mercury fell out while eating (b)(6) 2016. At the age of (b)(6), i noticed abdominal pain, irritability, lack of focus, fatigue all the time, mouth always taste like metal, shaky hands, and slurred speech. Including one side of my face looks slumped. Told my parents my mouth taste like metal all the time including dentist. They assured me i'm fine and the mercury is safe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062751 |
| MDR Report Key | 5710227 |
| Date Received | 2016-06-08 |
| Date of Event | 1990-05-01 |
| Date Added to Maude | 2016-06-09 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AMALGAM MERCURY FILLINGS |
| Generic Name | AMALGAM MERCURY FILLINGS |
| Product Code | OIV |
| Date Received | 2016-06-08 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Brand Name | AMALGAM MERCURY FILLINGS |
| Generic Name | AMALGAM MERCURY FILLINGS |
| Product Code | OIV |
| Date Received | 2016-06-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Brand Name | AMALGAM MERCURY FILLINGS |
| Generic Name | AMALGAM MERCURY FILLINGS |
| Product Code | OIV |
| Date Received | 2016-06-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Brand Name | AMALGAM MERCURY FILLINGS |
| Generic Name | AMALGAM MERCURY FILLINGS |
| Product Code | OIV |
| Date Received | 2016-06-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Brand Name | AMALGAM MERCURY FILLINGS |
| Generic Name | AMALGAM MERCURY FILLINGS |
| Product Code | OIV |
| Date Received | 2016-06-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Brand Name | AMALGAM MERCURY FILLINGS |
| Generic Name | AMALGAM MERCURY FILLINGS |
| Product Code | OIV |
| Date Received | 2016-06-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2016-06-08 |