EMBOTRAP II 5X33 REVASC. DEV. ET009533

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 2020-03-09 for EMBOTRAP II 5X33 REVASC. DEV. ET009533 manufactured by Neuravi Ltd..

MAUDE Entry Details

Report Number3011370111-2020-00020
MDR Report Key9808365
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-09
Date of Report2020-02-20
Date of Event2020-01-24
Date Mfgr Received2020-02-20
Device Manufacturer Date2019-07-04
Date Added to Maude2020-03-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 G1ADVANT MEDICAL
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY H91 PV0V
Manufacturer CountryEI
Manufacturer Postal CodeH91 PV0V
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEMBOTRAP II 5X33 REVASC. DEV.
Generic NameCATHETER, THROMBUS RETRIEVER
Product CodeNRY
Date Received2020-03-09
Model NumberET009533
Catalog NumberET009533
Lot Number19J187AV
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNEURAVI LTD.
Manufacturer AddressBLOCK 3 BALLYBRITT BUSINESS PARK GALWAY H91 K5YD EI H91 K5YD


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-09

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