MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-26 for UNK manufactured by Unk.
[109384]
Rptr claims she had 9 mercury containing dental amalgams placed in 1981. Rptr complains that since placement of amalgams she has experienced "mental disturbances", such as: inability to concentrate, panic attacks, impulsive behavior, excitability, and hearing voices in her head "like a radio transmission". Rptr states that symptoms have gotton progressively worse with age, as she is now 37 years old. Rptr states she has done extensive research at the library regarding the effects of mercury in humans, rptr claims "there is scientific evidence that proves mercury is poisonous, and goes straight to the brain. Mercury has been found to cause dementia". Rptr states that "no metal should be placed in a person's mouth, and it should be stopped. " rptr could not recall any mfr info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014467 |
| MDR Report Key | 184123 |
| Date Received | 1998-08-26 |
| Date of Report | 1998-08-26 |
| Date of Event | 1981-01-01 |
| Date Added to Maude | 1998-08-28 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | MERCURY DENTAL AMALGAM |
| Product Code | ELY |
| Date Received | 1998-08-26 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 179002 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-08-26 |