MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-13 for STAR DENTAL 430K manufactured by Unk.
[120456817]
After adult prophy pt stated she has a sharp restoration on tooth #5 distal. Bur that was used to smooth the filling by (b)(6). Bur fell into the pt's mouth and pt was instructed not to swallow. Pt ingested bur. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079815 |
| MDR Report Key | 7876620 |
| Date Received | 2018-09-13 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-09-06 |
| Date Added to Maude | 2018-09-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | STAR DENTAL |
| Generic Name | BUR, DENTAL |
| Product Code | EJL |
| Date Received | 2018-09-13 |
| Model Number | 430K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-13 |