EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED G48027 EVO-22-27-12-D

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 2019-09-12 for EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED G48027 EVO-22-27-12-D manufactured by .

MAUDE Entry Details

Report Number3001845648-2019-00470
MDR Report Key9009407
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-09-12
Date of Report2019-09-12
Date of Event2019-08-15
Date Facility Aware2019-08-15
Date Mfgr Received2019-08-16
Date Added to Maude2019-09-12
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 Phone061334440
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 NameEVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
Generic NameMUM STENT, METALIC EXPANDABLE, DUODENAL
Product CodeMUM
Date Received2019-09-12
Returned To Mfg2019-09-03
Model NumberG48027
Catalog NumberEVO-22-27-12-D
Lot NumberC1532216
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.