CORPATH GRX SYSTEM 312

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-09-04 for CORPATH GRX SYSTEM 312 manufactured by Corindus, Inc..

MAUDE Entry Details

Report Number3007822508-2019-00007
MDR Report Key8961205
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-09-04
Date of Report2019-09-04
Date of Event2019-07-29
Date Mfgr Received2019-07-30
Device Manufacturer Date2019-04-22
Date Added to Maude2019-09-04
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. ROBERT LAVADO
Manufacturer Street309 WAVERLEY OAKS ROAD SUITE 105
Manufacturer CityWALTHAM MA 02452
Manufacturer CountryUS
Manufacturer Postal02452
Manufacturer Phone5086533335
Manufacturer G1CORINDUS, INC.
Manufacturer Street309 WAVERLEY OAKS ROAD SUITE 105
Manufacturer CityWALTHAM MA 02452
Manufacturer CountryUS
Manufacturer Postal Code02452
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCORPATH GRX SYSTEM
Generic NameCORPATH GRX DEVICE
Product CodeDXX
Date Received2019-09-04
Model Number312
Catalog Number312
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCORINDUS, INC.
Manufacturer Address309 WAVERLEY OAKS ROAD SUITE 105 WALTHAM MA 02452 US 02452


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-04

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