MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-20 for CARBIDE BURS - FG 557SU PACK OF 10 DFG557SU manufactured by Integra York, Pa Inc..
[4371852]
Customer initially reports breaking. (b)(6), 2014 customer reports no harm done. Event details not available. Reventative measure used in general to prevent swallowing.
Patient Sequence No: 1, Text Type: D, B5
[11733636]
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 | 2523190-2014-00016 |
MDR Report Key | 3807238 |
Report Source | 06 |
Date Received | 2014-03-20 |
Date of Report | 2014-03-06 |
Date Mfgr Received | 2014-03-10 |
Date Added to Maude | 2014-06-02 |
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 PACK OF 10 |
Generic Name | M51 - GENERAL DENTISTRY |
Product Code | DSS |
Date Received | 2014-03-20 |
Catalog Number | DFG557SU |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INTEGRA YORK, PA INC. |
Manufacturer Address | YORK PA 17402 US 17402 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2014-03-20 |