Customer Complaint Notification

    1. Customer / Operator / Submitters


    Organisation Name*

    Contact Name*

    Contact EMail*




    2. Device Identifiation

    Model Description*

    Model No.*

    Lot / SN*

    Manufacturing date

    Expiry date

    3. Application

    Date when device has been implanted

    Date when device was explanted

    Date when the complaint was identified

    4. Complaint

    Provide a comprehensive description of the complaint, including (1) what went wrong with the device (if applicable) and (2) a description of the health effects (if applicable), i.e. clinical signs, symptoms, conditions as well as the overall health impact:*

    Number of Patients involved*

    Has the incident already been reported?*

    If Yes, Name of Authority

    5. General Comments