BIOMIMICS 3D VASCULAR STENT SYSTEM 131816-13

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2020-03-16 for BIOMIMICS 3D VASCULAR STENT SYSTEM 131816-13 manufactured by Veryan Medical.

MAUDE Entry Details

Report Number3011632150-2020-00022
MDR Report Key9834306
Report SourceFOREIGN,STUDY
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-02-11
Date Mfgr Received2020-02-21
Device Manufacturer Date2017-08-09
Date Added to Maude2020-03-16
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 ALAN MCDONAGH
Manufacturer StreetUNIT 11 GALWAY TECHNOLOGY PARK PARKMORE
Manufacturer CityGALWAY, GALWAY H91 VE0H
Manufacturer CountryEI
Manufacturer PostalH91 VE0H
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOMIMICS 3D VASCULAR STENT SYSTEM
Generic NameBIOMIMICS 3D VASCULAR STENT SYSTEM
Product CodeNIP
Date Received2020-03-16
Catalog Number131816-13
Lot Number414668
Device Expiration Date2019-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVERYAN MEDICAL
Manufacturer AddressUNIT 11 GALWAY TECHNOLOGY PARK PARKMORE GALWAY, GALWAY H91 VE0H EI H91 VE0H


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-16

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