CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS 3300TFX

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 2020-03-31 for CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS 3300TFX manufactured by Edwards Lifesciences.

MAUDE Entry Details

Report Number2015691-2020-11248
MDR Report Key9908049
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-06
Date of Event2020-03-06
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-31
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. AMRITHA SRINIVASAN
Manufacturer StreetONE EDWARDS WAY MLE-2
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492504062
Manufacturer G1EDWARDS LIFESCIENCES LLC
Manufacturer StreetONE EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
Generic NameHEART-VALVE, REPLACEMENT
Product CodeDYE
Date Received2020-03-31
Model Number3300TFX
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES
Manufacturer AddressONE EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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