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 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 Number1718850-2019-01191
MDR Report Key9392073
Date Received2019-11-29
Date of Report2019-11-04
Date of Event2019-10-11
Date Facility Aware2019-11-04
Report Date2019-11-04
Date Reported to Mfgr2019-11-04
Date Mfgr Received2019-11-04
Date Added to Maude2019-11-29
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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 CountryUS
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 Age19 MO
Device Eval'ed by Mfgr*
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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