Practical guide

What to write in the record after a filler or botulinum toxin

This guide lists what to note in the record right after an injection of filler or botulinum toxin. It gives no doses and no indications: it says what must be written so that the session can be reconstructed years later. A printable checklist closes the page.

Product, batch and expiry

Write the commercial name as it appears on the packaging, the batch number and the expiry date; if present, copy the UDI too, the unique device identifier. The batch lets you answer the question “which patients received this package” on the day the manufacturer recalls it or an adverse event appears. For fillers, implementing regulation 2022/2346 provides an information card that the manufacturer's instructions ask you to hand to the patient before treatment, with a part for recording the site, number and volume of injections for each consumer. In the texts we read, however, there is no general obligation to keep a card with the batch for every filler.

Why the batch matters: the rules

Facial fillers fall under the European medical device regulation (2017/745) even when the purpose is only aesthetic: annex XVI says so. Legislative decree 137 of 2022 (art. 15) says healthcare operators record and keep the UDI of the devices they received, according to decrees of the Minister of Health: we did not find that implementing decree. Article 10 requires reporting a serious incident with a device, even a suspected one, to the Ministry of Health, and article 27 sets a fine of 26,000 to 120,000 euros for those who omit the report. To report it you must know which product and which batch you used. For botulinum toxin we have not read a specific rule on recording the batch.

Quantity, sites and technique

Write the quantity in the unit of the product you used, without converting: the FDA label of BOTOX warns that its units are not interchangeable with those of other toxins. Mark every treated site, symmetrical ones included, with the quantity for each site. Describe the technique: needle or cannula, with the gauge, and the plane of injection (for example subdermal). A 2018 consensus on visual complications after filler lists among the data to record the product, the volume and the site injected, and the needle or cannula with its size.

What you told the patient

Record the instructions you gave after treatment and when you gave them: the code of medical ethics wants the way and time of the information in the record (art. 26). In a study on nose filler, on the day of injection patients received a sheet asking them to report at once swelling, pain, tingling, changes in sensation and visual disturbances, above all in the first 12 to 72 hours. For botulinum toxin, a 2023 review writes that post-injection recommendations rest mostly on experience and have little evidence behind them. So note which ones you gave, without presenting them as the only correct practice.

Follow-up and complications

Write the date of the follow-up. The effect of the toxin keeps increasing for one to two weeks after injection, and the 2023 review advises those who notice an unsatisfactory result in the first days to wait a few days before touching up. If a complication appears, take the 2018 consensus on visual complications as a model: document precisely the events, the time of onset, the actions taken, the photographs and all communications between patient, practice and specialist facility, and inform the professional liability insurer.

In Fibonacci

In the treatment form the batch is entered as printed on the packaging, with the expiry and, if you wish, the UDI. The program records and does not calculate: if a value looks inconsistent it warns, but does not block saving. Areas are marked on the face map, with the quantity for each point, and for each point you can state instrument, gauge, plane and technique. From every session you can download a PDF file with product, batch, expiry, quantity, areas, technique, consents and photos. The recall reminder is for the practice: no message goes to the patient.

To print

The checklist

Write the commercial name, batch and expiry as they appear on the packaging.
If the packaging carries a UDI, copy it.
Note the quantity in the unit of the product used, without converting between brands.
Mark every treated site, with the quantity for each site.
Write the instrument (needle or cannula), the gauge and the plane of injection.
For fillers, hand over the manufacturer's card before treating and note that you did.
Write the instructions given to the patient and when you gave them.
Set and write the date of the follow-up.
If a complication appears, record events, time of onset, actions, photos and communications, and notify the insurer.
Report a serious incident with a device to the Ministry of Health, even a suspected one.

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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