CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL M7-025

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 2019-11-29 for CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL M7-025 manufactured by Sorin Group Italia S.r.l..

MAUDE Entry Details

Report Number3005687633-2019-00265
MDR Report Key9392075
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-10-11
Date Mfgr Received2019-11-04
Device Manufacturer Date2018-03-27
Date Added to Maude2019-11-29
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 FRANCESCA CROVATO
Manufacturer Street5005 NORTH FRASER WAY
Manufacturer CityBURNABY, BRITISH COLUMBIA V5J5M1
Manufacturer CountryCA
Manufacturer PostalV5J5M1
Manufacturer G1SORIN GROUP ITALIA S.R.L.
Manufacturer StreetSTRADA CRESCENTINO SNC
Manufacturer CitySALUGGIA, VERCELLI 13040
Manufacturer CountryIT
Manufacturer Postal Code13040
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
Generic NameMECHANICAL HEART VALVE PROSTHESIS
Product CodeLWQ
Date Received2019-11-29
Model NumberM7-025
Catalog NumberM7-025
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSORIN GROUP ITALIA S.R.L.
Manufacturer AddressSTRADA CRESCENTINO SNC SALUGGIA, VERCELLI 13040 IT 13040


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-29

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