CONTEGRA 200H18

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 2019-11-22 for CONTEGRA 200H18 manufactured by Medtronic Heart Valve Division.

MAUDE Entry Details

Report Number2025587-2019-03561
MDR Report Key9364208
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-22
Date of Report2019-11-22
Date of Event2013-06-28
Date Mfgr Received2019-11-06
Device Manufacturer Date2009-04-27
Date Added to Maude2019-11-22
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC HEART VALVE DIVISION
Manufacturer Street1851 E DEERE AVE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal Code92705
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONTEGRA
Generic NameCONDUIT,VALVED,PULMONIC
Product CodeMWH
Date Received2019-11-22
Model Number200H18
Catalog Number200H18
Device Expiration Date2012-03-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC HEART VALVE DIVISION
Manufacturer Address1851 E DEERE AVE SANTA ANA CA 92705 US 92705


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-22

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