EU 4.5X14MM STENT 12 MM DW TIP ENC451412

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-23 for EU 4.5X14MM STENT 12 MM DW TIP ENC451412 manufactured by Codman And Shurtleff, Inc.

MAUDE Entry Details

Report Number1226348-2019-01006
MDR Report Key9227434
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-23
Date of Report2019-09-28
Date of Event2019-09-18
Date Mfgr Received2019-11-07
Device Manufacturer Date2019-06-20
Date Added to Maude2019-10-23
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 ContactMR. GABRIEL ALFAGEME
Manufacturer Street31 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone949789-868
Manufacturer G1CODMAN AND SHURTLEFF, INC
Manufacturer Street325 PARAMOUNT DR
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEU 4.5X14MM STENT 12 MM DW TIP
Generic NameINTRACRANIAL NEUROVASCULAR STENT
Product CodeNJE
Date Received2019-10-23
Returned To Mfg2019-10-25
Catalog NumberENC451412
Lot Number11153593
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCODMAN AND SHURTLEFF, INC
Manufacturer Address325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-23

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