CARDIOCEL EC0404

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-11-25 for CARDIOCEL EC0404 manufactured by Admedus Regen Pty Ltd.

MAUDE Entry Details

Report Number3010805634-2019-00004
MDR Report Key9367801
Report SourceFOREIGN
Date Received2019-11-25
Date of Report2019-11-24
Date of Event2017-07-01
Date Mfgr Received2018-01-19
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. SEONA ROBERTS
Manufacturer Street26 HARRIS ROAD
Manufacturer CityMALAGA, WEST AUSTRALIA 6090
Manufacturer CountryAS
Manufacturer Postal6090
Manufacturer G1ADMEDUS REGEN PTY LTD
Manufacturer Street26 HARRIS ROAD
Manufacturer CityMALAGA, WEST AUSTRALIA 6090
Manufacturer CountryAS
Manufacturer Postal Code6090
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARDIOCEL
Generic NameCARDIOVASCULAR PATCH
Product CodeDXZ
Date Received2019-11-25
Model NumberEC0404
Catalog NumberEC0404
Lot Number13052054-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerADMEDUS REGEN PTY LTD
Manufacturer Address26 HARRIS ROAD MALAGA, WEST AUSTRALIA 6090 AS 6090


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-25

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