GEENEN PANCREATIC STENT UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-29 for GEENEN PANCREATIC STENT UNKNOWN manufactured by Cook Ireland Ltd.

MAUDE Entry Details

Report Number3001845648-2019-00646
MDR Report Key9391605
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-11-01
Date Mfgr Received2019-11-13
Date Added to Maude2019-11-29
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 ContactMS. HEATHER RYAN
Manufacturer StreetO HALLORAN ROAD NATIONAL TECHNOLOGY PARK
Manufacturer CityLIMERICK
Manufacturer G1COOK IRELAND LTD
Manufacturer StreetO HALLORAN ROAD NATIONAL TECHNOLOGY PARK
Manufacturer CityLIMERICK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGEENEN PANCREATIC STENT
Generic NameFGE CATHETER, BILIARY, DIAGNOSTIC
Product CodeFGE
Date Received2019-11-29
Catalog NumberUNKNOWN
Lot NumberUNKNONW
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK IRELAND LTD
Manufacturer AddressO HALLORAN ROAD LIMERICK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-29

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