CARBIDE BURS - FG 557SU PACK OF 10 DFG557SU

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number2523190-2014-00016
MDR Report Key3807238
Report Source06
Date Received2014-03-20
Date of Report2014-03-06
Date Mfgr Received2014-03-10
Date Added to Maude2014-06-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSANDRA LEE
Manufacturer Street315 ENTERPRISE DRIVE
Manufacturer Phone6099366828
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARBIDE BURS - FG 557SU PACK OF 10
Generic NameM51 - GENERAL DENTISTRY
Product CodeDSS
Date Received2014-03-20
Catalog NumberDFG557SU
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer AddressYORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2014-03-20

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