CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-023

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-023 manufactured by Sorin Group Italia S.r.l..

MAUDE Entry Details

Report Number1718850-2020-01027
MDR Report Key9821956
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2014-03-10
Date Facility Aware2020-02-13
Report Date2020-02-13
Date Reported to Mfgr2020-02-13
Date Mfgr Received2020-02-13
Date Added to Maude2020-03-11
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 TOP HAT MECHANICAL HEART VALVE
Generic NameMECHANICAL HEART VALVE PROSTHESIS
Product CodeLWQ
Date Received2020-03-11
Model NumberS5-023
Catalog NumberS5-023
Device Expiration Date2017-08-17
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age18 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 2020-03-11

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