MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-10 for DENTAL CROWN manufactured by 3 M Company.
[1760968]
Pt had a dental filling and crowns. Steel crown done on primary teeth. Couple months later pt started experiencing seizures. Seizures first started as "jerking" then grand mal seizure. Mom took pt to neurologist. Anti seizures medication was prescribed but seizures still persist. Mom took pt to another pedodontist and had the crown removed. After crown was removed the seizures stopped. Pt's mom wants warning label on crowns, and dental filling material of possible risk etc seizures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018633 |
| MDR Report Key | 1933945 |
| Date Received | 2010-12-10 |
| Date of Report | 2010-12-10 |
| Date of Event | 2010-02-16 |
| Date Added to Maude | 2010-12-23 |
| 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 |
| 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 |
| Generic Name | DENTAL CROWN |
| Product Code | ELZ |
| Date Received | 2010-12-10 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3 M COMPANY |
| Generic Name | DENTAL FILLING MATERIAL |
| Product Code | EJJ |
| Date Received | 2010-12-10 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | 3 M COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-10 |