CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-021

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-11 for CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-021 manufactured by Sorin Group Italia S.r.l..

MAUDE Entry Details

• Report Number: 3005687633-2020-00106
• MDR Report Key: 9822018
• Report Source: HEALTH PROFESSIONAL,LITERATUR
• Date Received: 2020-03-11
• Date of Report: 2020-03-11
• Date of Event: 2016-08-24
• Date Mfgr Received: 2020-02-13
• Device Manufacturer Date: 2015-08-31
• Date Added to Maude: 2020-03-11
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS FRANCESCA CROVATO
• Manufacturer Street: 5005 NORTH FRASER WAY
• Manufacturer City: BURNABY, BRITISH COLUMBIA V5J5M1
• Manufacturer Country: CA
• Manufacturer Postal: V5J5M1
• Manufacturer G1: SORIN GROUP ITALIA S.R.L.
• Manufacturer Street: STRADA CRESCENTINO SNC
• Manufacturer City: SALUGGIA, VERCELLI 13040
• Manufacturer Country: IT
• Manufacturer Postal Code: 13040
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Generic Name: MECHANICAL HEART VALVE PROSTHESIS
• Product Code: LWQ
• Date Received: 2020-03-11
• Model Number: S5-021
• Catalog Number: S5-021
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SORIN GROUP ITALIA S.R.L.
• Manufacturer Address: STRADA CRESCENTINO SNC SALUGGIA, VERCELLI 13040 IT 13040

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-11