Customer Complaint Notification

A separate complaint form must be completed for each LOT or for each patient. Combining different LOTs or patients in a single submission is not permitted.

    1. Customer / Operator / Submitters


    *required

    Organisation Name*

    Contact Name*

    Contact EMail*

    Adress*

    Country*

    Phone*





    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