BURR, OVAL, 8 FLUTE 4.0MM X 13CM AR-8400OBE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-09-10 for BURR, OVAL, 8 FLUTE 4.0MM X 13CM AR-8400OBE manufactured by Arthrex, Inc..

MAUDE Entry Details

Report Number1220246-2019-01305
MDR Report Key8980908
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-09-10
Date of Report2019-09-10
Date of Event2019-08-20
Date Mfgr Received2019-08-21
Device Manufacturer Date2019-03-27
Date Added to Maude2019-09-10
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 ContactVIK BAJNATH
Manufacturer Phone8009337001
Manufacturer G1ARTHREX, INC.
Manufacturer Street1370 CREEKSIDE BOULEVARD
Manufacturer CityNAPLES FL 341081945
Manufacturer CountryUS
Manufacturer Postal Code341081945
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBURR, OVAL, 8 FLUTE 4.0MM X 13CM
Generic NameBURR, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGFF
Date Received2019-09-10
Model NumberBURR, OVAL, 8 FLUTE 4.0MM X 13CM
Catalog NumberAR-8400OBE
Lot Number10293299
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerARTHREX, INC.
Manufacturer Address1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-10

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