UNKPULSERIDER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-04 for UNKPULSERIDER manufactured by Pulsar Vascular.

MAUDE Entry Details

Report Number3008680601-2020-00005
MDR Report Key9666926
Report SourceLITERATURE
Date Received2020-02-04
Date of Report2020-01-15
Date Mfgr Received2020-01-15
Date Added to Maude2020-02-04
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. GABRIEL ALFAGEME
Manufacturer Street31 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone949789-868
Manufacturer G1PULSAR VASCULAR
Manufacturer Street130 KNOWLES DR SUITE E
Manufacturer CityLOS GATOS CA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKPULSERIDER
Generic NameINTRACRANIAL NEUROVASCULAR STENT
Product CodeNJE
Date Received2020-02-04
Catalog NumberUNKPULSERIDER
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPULSAR VASCULAR
Manufacturer Address130 KNOWLES DR SUITE E LOS GATOS CA 95032 US 95032


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-04

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