4.0MM ROUND FAST CUTTING BUR 1608006137

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-30 for 4.0MM ROUND FAST CUTTING BUR 1608006137 manufactured by Stryker Instruments-kalamazoo.

MAUDE Entry Details

Report Number0001811755-2019-03593
MDR Report Key9258227
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-30
Date of Report2019-10-30
Date of Event2019-09-30
Date Mfgr Received2019-09-30
Device Manufacturer Date2019-08-18
Date Added to Maude2019-10-30
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 FDA3
Event Location3
Manufacturer ContactMRS. UNA BARRY
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer PostalNA
Manufacturer Phone214532900
Manufacturer G1STRYKER INSTRUMENTS-IRELAND
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name4.0MM ROUND FAST CUTTING BUR
Generic NameBUR, DENTAL
Product CodeEJL
Date Received2019-10-30
Catalog Number1608006137
Lot Number19231017
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-30

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