CARBIDE BUR CAV.CYL.SQUARE FG 010 E013734101000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-09-05 for CARBIDE BUR CAV.CYL.SQUARE FG 010 E013734101000 manufactured by Dentsply Maillefer.

MAUDE Entry Details

Report Number8031010-2019-00175
MDR Report Key8966912
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-09-05
Date of Report2019-09-05
Date Mfgr Received2019-08-06
Date Added to Maude2019-09-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
Manufacturer G1DENTSPLY MAILLEFER
Manufacturer StreetCHEMIN DU VERGER 3
Manufacturer CityBALLAIGUES, 1338
Manufacturer CountrySZ
Manufacturer Postal Code1338
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARBIDE BUR CAV.CYL.SQUARE FG 010
Generic NameBUR, DENTAL
Product CodeEJL
Date Received2019-09-05
Model NumberNA
Catalog NumberE013734101000
Lot Number1426885
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY MAILLEFER
Manufacturer AddressCHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-05

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