ARTEMIS NEURO EVACUATION DEVICE AP28

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 2019-06-04 for ARTEMIS NEURO EVACUATION DEVICE AP28 manufactured by Penumbra, Inc..

MAUDE Entry Details

Report Number3005168196-2019-01017
MDR Report Key8666312
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-06-04
Date of Report2019-05-05
Date of Event2018-06-19
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2019-06-04
Device Manufacturer Date2017-10-30
Date Added to Maude2019-06-04
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 ContactMS. VERONICA FARRIS
Manufacturer StreetONE PENUMBRA PLACE
Manufacturer CityALAMEDA CA 94502
Manufacturer CountryUS
Manufacturer Postal94502
Manufacturer Phone5107483200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTEMIS NEURO EVACUATION DEVICE
Generic NameGWG
Product CodeGWG
Date Received2019-06-04
Catalog NumberAP28
Lot NumberS10003
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPENUMBRA, INC.
Manufacturer AddressONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2019-06-04

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