SENTINEL CEREBRAL PROTECTION SYSTEM (US) CMS15-10C-US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-12 for SENTINEL CEREBRAL PROTECTION SYSTEM (US) CMS15-10C-US manufactured by Claret Medical, Inc..

MAUDE Entry Details

Report Number2134265-2019-05947
MDR Report Key8693328
Report SourceHEALTH PROFESSIONAL
Date Received2019-06-12
Date of Report2019-06-12
Date of Event2019-05-07
Date Mfgr Received2019-05-16
Date Added to Maude2019-06-12
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 ContactSONALI ARANGIL
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone6515827403
Manufacturer G1CLARET MEDICAL, INC.
Manufacturer Street1745 COPPERHILL PARKWAY
Manufacturer CitySANTA ROSA CA 95403
Manufacturer CountryUS
Manufacturer Postal Code95403
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSENTINEL CEREBRAL PROTECTION SYSTEM (US)
Generic NameEMBOLIC PROTECTION DEVICE
Product CodePUM
Date Received2019-06-12
Model NumberCMS15-10C-US
Catalog NumberCMS15-10C-US
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCLARET MEDICAL, INC.
Manufacturer Address1745 COPPERHILL PARKWAY SANTA ROSA CA 95403 US 95403


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-06-12

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