Materiovigilance Notification Form

Reporter

Last name, First name
Position
Address-Phone-Fax-E-mail
Healthcare institution Association / Manufacturer Home
Other

MEDICAL DEVICE INVOLVED

Common name
Trade name
Model
Type
Reference

Serial or Lot number
Software version
Supplier's name and address
Manufacturer's name and address

INCIDENT OR POTENTIAL INCIDENT

Date of occurrence
Location of occurrence
User references
Circumstances of occurrence / Description of facts
Observed clinical consequences
Conservative measures and actions taken

I, the undersigned, hereby declare on my honor that the information provided above is accurate, truthful, and complete, and consent to the collection and processing of my personal data by Bottu, in accordance with the provisions of Law No.09-08 relating to the protection of individuals with regard to the processing of personal data. This processing has been declared to the CNDP. You may contact Ms. Layla HMAOUI to exercise your rights of access, rectification, and objection in accordance with the provisions of Law No. 09-08 by calling the following telephone number: 0522355350.