PMCF Data Collection Questionnaire

    Post-Market Clinical Follow-up

    1. Client / Respondent type

    2. Device / Product information

    Note: Please complete one form per product type / patient type.

    3. Target user group

    Additional fields:

    Application period:

    4. Type of treatment

    Please indicate for which type of treatment the device was prescribed or used.

    Dermal filler treatment

    Treatment of defects

    5. Treatment efficacy

    Please rate the following aspects

    Filling capacity
    Ease of preparing / assembling the syringe
    Ease of extracting the solution
    Ability to properly manage the treatment
    Ability to improve patient comfort

    6. Device compliance / usability

    Please rate the following aspects

    Ease of opening the box
    Ease of opening / closing the container cap
    Ease of handling the syringe
    Ease of applying the product
    Completeness and clarity of the instructions for use
    Tolerability
    Pleasantness / overall user experience

    Additional field:

    7. Use of the device

    Was the device used in accordance with the instructions for use?

    Were the instructions for use clear for the intended use of the device?

    8. Benefits of use

    Is the medical device able to provide benefits to the user as indicated in the instructions for use?

    Are there any advantages that can be identified when using this device compared to competing products?

    9. Possible undesirable effects

    Please select / describe if applicable

    Undesirable effects

    Unknown undesirable effects

    Was the device used together with other devices and/or medicinal products?

    If yes, did any undesirable effects occur?

    Adverse events / incidents that occurred during use of the device

    10. Suggestions / notes

    11. Respondent confirmation