MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-10-10 for CARBIDE BURS - FG 557SU DFG557SU manufactured by Miltex Inc..
[3034414]
Customer initially reports device defective, keep breaking. On (b)(6) 2012 dental assistant reports burrs breaking when cutting tooth and bone, fear patient could swallow broken piece.
Patient Sequence No: 1, Text Type: D, B5
[10212786]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00085 |
| MDR Report Key | 2785235 |
| Report Source | 06 |
| Date Received | 2012-10-10 |
| Date of Report | 2012-10-10 |
| Date Mfgr Received | 2012-10-04 |
| Date Added to Maude | 2013-01-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARBIDE BURS - FG 557SU |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | DSS |
| Date Received | 2012-10-10 |
| Catalog Number | DFG557SU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTEX INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-10 |