ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG G48451 TFLE-12-90-ZT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-30 for ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG G48451 TFLE-12-90-ZT manufactured by Cook Inc.

MAUDE Entry Details

Report Number1820334-2020-00711
MDR Report Key9898697
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2019-06-11
Date Mfgr Received2020-03-16
Device Manufacturer Date2019-04-22
Date Added to Maude2020-03-30
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. JENNIFER CANADA
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG
Generic NameMIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Product CodeMIH
Date Received2020-03-30
Returned To Mfg2019-06-18
Model NumberG48451
Catalog NumberTFLE-12-90-ZT
Lot Number9647374
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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