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..
[3034413]
Customer initially reports the burs keep snapping off. On (b)(6) 2012, dental assistant reports burrs are frequently breaking when cutting teeth and they fear patient could swallow burr tip.
Patient Sequence No: 1, Text Type: D, B5
[10212784]
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 | 2523190-2012-00084 |
| MDR Report Key | 2785233 |
| 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 |