MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-07-16 for CARBIDE BURS - FG 557SU PACK OF 10 DRG557SU manufactured by Miltex, Inc..
[2816105]
Customer initially reports that burs keep breaking at head; no pt injury. On (b)(6) 2012, certified dental assistant reports via phone that burs break off and lodge in a tooth and/or break off and are suctioned out of mouth. Though it has not happened, they fear pt swallowing bur. This is a recent occurrence, doctor generally prefers integra burs.
Patient Sequence No: 1, Text Type: D, B5
[10074983]
To date, the device involved in the reported incident has not been received for further evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00064 |
| MDR Report Key | 2662522 |
| Report Source | 06 |
| Date Received | 2012-07-16 |
| Date of Report | 2012-07-13 |
| Date Mfgr Received | 2012-07-05 |
| Date Added to Maude | 2012-11-05 |
| 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 |
| Reporter Occupation | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099366826 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARBIDE BURS - FG 557SU PACK OF 10 |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | DSS |
| Date Received | 2012-07-16 |
| Catalog Number | DRG557SU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-07-16 |