Practical guide

After a complication: what to document and whom to notify

This guide does not say how to treat a complication: that is your craft and depends on the case. It says what to put in writing, what to tell the patient, and what the law asks you to report and to whom, with the deadlines written in the texts.

Write in the record what happened and what you did

Note when the patient reported the complication or you observed it, what you observed, what you did and at what time, and which session, product and batch you link it to. The code of medical ethics, article 26, asks for a record drawn up “with completeness, clarity and diligence”, which records the course “as it unfolds” and in which corrections are “reasoned and signed”: the article is written for the inpatient record, but the principle does not change. An expert group on dermal fillers recommends documenting thoroughly the technique, the name and amount of the product and the areas treated, and attaching the batch label to the consent form or the record; among the minimum information of an aesthetic record it also lists the assessment of adverse effects. Do not rewrite old notes: add a note with date and time.

Photograph the complication the way you photographed the treatment

For clinical photographs of the face the same expert group recommends standardized shots at 0, 45 and 90 degrees, right and left, plus dynamic photographs to see asymmetries. If you have the series from before the treatment, repeat the same framings and date every shot. The photographs stay in the record: they serve care and the reconstruction of what happened, and they go nowhere else. The Garante case that ended in a 20,000-euro fine concerned photos taken for internal use and then published. If the patient asks for them, they are health data and fall within the copy of the record.

Tell the patient, and write that you did

Law 219 of 2017, article 1, paragraph 3, recognizes every person's right to know their health condition and to be informed “in a complete, up-to-date and comprehensible way” about diagnosis, prognosis, benefits and risks of treatments, and alternatives. The code of medical ethics, article 14, lists among the tools of care safety attention to the “communication of an undesired event and its causes”. In the record write when you talked about it, what you said, what the patient decided and when the next check is. The filler expert group considers it essential to tell the patient how to behave after the treatment: leave in writing whom to call.

If a device is involved: when to report to the Ministry

The decree of the Minister of Health of 1 July 2025, published in the Gazzetta on 19 September 2025 and in force after one hundred and eighty days, applies to medical devices and to those in Annex XVI of the European Regulation 2017/745, which covers dermal fillers and laser and pulsed-light equipment for skin treatments. A healthcare operator who detects a serious incident, even only suspected, must report it to the Ministry of Health “promptly and in any case no later than ten days from” becoming aware of the event (article 4, paragraph 1). Under the European Regulation an incident is serious if it caused, may have caused or may cause death, a serious deterioration, temporary or permanent, of the state of health, or a serious public health threat. A non-serious incident you may report, you are not obliged to, within thirty days. If a serious incident is not reported, the penalty ranges from 26,000 to 120,000 euros (Legislative Decree 137 of 2022, article 27, paragraph 45).

To whom and how you report

The report is made online on the Ministry form, with CNS, CIE or SPID (article 2 of the 2025 decree), by the healthcare operator or by the regional vigilance contact, directly or through the facility (Legislative Decree 137 of 2022, article 10, paragraph 4). The legislative decree asks for the communication to be sent also to the manufacturer or its authorized representative, including through the distributor, and for complaints to be reported to the manufacturer with the Ministry informed (article 10, paragraphs 5 and 6). The report must not contain data that identify the patient (article 2, paragraph 6): write the event and the product, not the name. If the product is a medicine, such as botulinum toxin, the code of medical ethics (article 13) asks to report promptly to the competent authority adverse or suspected reactions: the channel and the deadline for medicines we have not read. In Fibonacci the complication is recorded from the row of the session, with product and batch, and the report sheet prepares the text to copy into the form, without the patient's data and without transmitting anything.

The insurer: what the texts say

Law 24 of 2017 sets no deadline for notifying the insurer: Ministerial Decree 232 of 2023, article 5, paragraph 3, does. The insured must give notice within thirty days of the day the claim arrived or became known, and under the decree a “claim” is the written request for compensation made for the first time by third parties (article 1, letter o): the complication alone is not one, nor is a request for the clinical record. The decree does not say whether you must give notice earlier, for a complication that might generate a claim: check your policy. The insurer, for its part, must tell you when a lawsuit against it begins, within forty-five days of service (Law 24, article 13), and failure to do so bars the recourse action. The policy covers claims made while it is in force for acts of the preceding ten years (Decree 232, article 5, paragraph 1): that is why today's documentation must remain retrievable.

To print

The checklist

Write in the record what happened, what you did and at what time, without rewriting old notes.
Link the complication to the session, the product and the batch.
Photograph with the same framings as the series before the treatment and date every shot.
Keep the photos in the record: they do not go on social media or into personal archives.
Tell the patient what happened, so that she understands, and write when and what you told her.
Write the date of the next check and whom to call.
If a device is involved and the incident is serious, even only suspected, report it to the Ministry within ten days of knowing.
Send the report also to the manufacturer or its authorized representative, and do not write the patient's name.
Read your policy: it says whether and when it wants to be notified before a claim for damages.
If a claim for damages arrives, notify the insurer within thirty days.

Sources

This guide explains what the cited laws and literature say. It is not legal advice or a clinical opinion on a case: for those you need your lawyer or a colleague.

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