EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX CDK-1413

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 2019-06-24 for EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX CDK-1413 manufactured by Atricure, Inc..

MAUDE Entry Details

Report Number3011706110-2019-00031
MDR Report Key8726828
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-06-24
Date of Report2019-06-24
Date of Event2019-05-29
Date Mfgr Received2019-05-29
Date Added to Maude2019-06-24
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. JOHN EHLERT
Manufacturer Street7555 INNOVATION WAY
Manufacturer CityMASON OH 45040
Manufacturer CountryUS
Manufacturer Postal45040
Manufacturer Phone5137554563
Manufacturer G1ATRICURE, INC.
Manufacturer Street7555 INNOVATION WAY
Manufacturer CityMASON OH 45040
Manufacturer CountryUS
Manufacturer Postal Code45040
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
Generic NameEPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
Product CodeOCL
Date Received2019-06-24
Model NumberCDK-1413
Catalog NumberCDK-1413
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerATRICURE, INC.
Manufacturer Address7555 INNOVATION WAY MASON OH 45040 US 45040


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2019-06-24

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