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 Number: 3005687633-2019-00265
• MDR Report Key: 9392075
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-11-29
• Date of Report: 2019-11-29
• Date of Event: 2019-10-11
• Date Mfgr Received: 2019-11-04
• Device Manufacturer Date: 2018-03-27
• Date Added to Maude: 2019-11-29
• 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 STANDARD PROSTHETIC HEART VALVE, MITRAL
• Generic Name: MECHANICAL HEART VALVE PROSTHESIS
• Product Code: LWQ
• Date Received: 2019-11-29
• Model Number: M7-025
• Catalog Number: M7-025
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• 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	2019-11-29