MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-05 for MERCURY AMALGAM DENTAL FILLING manufactured by Unk.
[101659915]
Pt reports his life has been destroyed by the device and is now suicidal. Dating back to when the pt was (b)(6), he accidentally ingested the mercury amalgam during a procedure and immediately felt symptoms once he was discharged home. He experienced dizziness and vomiting among other symptoms. The pt has also read multiple similar pt reactions to this product online, and believes himself and other have been poisoned. The pt was referred to national suicide prevention.
Patient Sequence No: 1, Text Type: D, B5
[101890694]
Additional information received from reporter for report mw5075652: reporter states that after he swallowed his amalgam filling in 1987 he has experienced pain "all over" including his brain, every day for the past 31 years. He goes on to say that he is tired and frustrated that he has to go through this and wants no other children to go through what he has gone through. He added that he believes that this filling may have made him autistic. Reporter states that he is not suicidal today ((b)(6) 2018).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075652 |
| MDR Report Key | 7316263 |
| Date Received | 2018-03-05 |
| Date of Report | 2018-03-05 |
| Date of Event | 1987-01-01 |
| Date Added to Maude | 2018-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 | 3 |
| Brand Name | MERCURY AMALGAM DENTAL FILLING |
| Generic Name | MERCURY AMALGAM |
| Product Code | OIV |
| Date Received | 2018-03-05 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-03-05 |