INDIGO SYSTEM SEPARATOR 6 SEP6

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-25 for INDIGO SYSTEM SEPARATOR 6 SEP6 manufactured by Penumbra, Inc..

MAUDE Entry Details

Report Number3005168196-2019-02183
MDR Report Key9373301
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-25
Date of Report2019-10-29
Date of Event2019-10-29
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2019-10-29
Device Manufacturer Date2019-05-16
Date Added to Maude2019-11-25
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 Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameINDIGO SYSTEM SEPARATOR 6
Generic NameQEW
Product CodeQEW
Date Received2019-11-25
Catalog NumberSEP6
Lot NumberF90305
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerPENUMBRA, INC.
Manufacturer AddressONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-25

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