MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-08 for DISPERSALLOY manufactured by Dentsply International.
[19461350]
The patient had a large mercury filling placed by another dentist and almost immediately went into a bout of inexplicable depression, and tremors in his hands. Fortunately, his common sense prevailed, and he looked towards what changes had occurred in his life prior to this event. He looked towards the mercury filling as a cause, and sought me out to remediate the mercury toxic event. Using the correct protocol for removal, and with chelation of body mercury with a holistic md, the symptoms almost immediately were reversed. Dates of use: 3 weeks (b) (6) 2010 -- (b) (6) 2010. Diagnosis or reason for use: decay of teeth. Event abated after use stopped or dose reduced? : yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015921 |
| MDR Report Key | 1686073 |
| Date Received | 2010-05-08 |
| Date of Report | 2010-05-08 |
| Date of Event | 2010-04-01 |
| Date Added to Maude | 2010-05-17 |
| 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 | DENTIST |
| 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 | DISPERSALLOY |
| Generic Name | MERCURY FILLING MATERIAL |
| Product Code | EJJ |
| Date Received | 2010-05-08 |
| Lot Number | 93993-10 |
| ID Number | 9889-5674 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY INTERNATIONAL |
| Manufacturer Address | WILMINGTON DE US |
| Brand Name | DISPERSALLOY |
| Generic Name | MERCURY FILLING MATERIAL |
| Product Code | EJJ |
| Date Received | 2010-05-08 |
| Lot Number | 9696969 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY INTERNATIONAL |
| Manufacturer Address | WILMINGTON DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-05-08 |