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Field Safety Corrective Action Report Form
Medical Devices Vigilance System
(MEDDEV 2.12/1 rev 8)
v.01.13
Page 1 of 5
1. Administrative Information
Destination
Ministry of Health
Vigilance on Medical Devices
Via Giorgio Ribotta 5, IT - 00144 Roma
Italy
Type of Report
Initial report
Follow up report
Final report
Date of this Report
30 October 2015
Reference Number Assigned by Manufacturer
21833502-01/19/2015-001-R
FSCA Reference Number Assigned by NCA
2015/001/029/071/001
Incidence Reference Number Assigned by NCA
N/A
Name of the Coordinating National Competent Authority (if applicable)
MHRA
2. Information on Submitter of the Report
Status of submitter
Manufacturer
Authorised Representative within EEA, Switzerland and Turkey
Others: (identify the role):
Smiths Medical Risk Management Specialist on Manufacturer’s Behalf
3. Manufacturer Information
Manufacturer Name
Smiths Medical ASD, Inc.
Manufacturer’s Contact Person
Tim Giguere
Address
1265 Grey Fox Road
Postal Code
55112
City
St. Paul
Phone
651 628 7477
Fax
n/a
E-mail
tim.giguere@smiths-medical.com
Country
USA
4. Authorised Representative Information
Name of Authorised Representative
Smiths Medical International Ltd.