CARBOMEDICS REDUCED AORTIC VALVE R5-021

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-26 for CARBOMEDICS REDUCED AORTIC VALVE R5-021 manufactured by Sorin Group Italia Srl.

MAUDE Entry Details

Report Number3005687633-2020-00109
MDR Report Key9884808
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2020-03-26
Date of Report2020-03-23
Date of Event2020-02-24
Date Mfgr Received2020-02-25
Device Manufacturer Date2019-05-17
Date Added to Maude2020-03-26
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, BC V5J 5M1
Manufacturer CountryCA
Manufacturer PostalV5J 5M1
Manufacturer G1SORIN GROUP ITALIA SRL
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 REDUCED AORTIC VALVE
Generic NameMECHANICAL HEART VALVE PROSTHESIS
Product CodeLWQ
Date Received2020-03-26
Model NumberR5-021
Catalog NumberR5-021
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSORIN GROUP ITALIA SRL
Manufacturer AddressSTRADA CRESCENTINO SNC SALUGGIA, VERCELLI 13040 IT 13040


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-26

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