Product Batch Record and Traceability Template
When a patient has a complication or the manufacturer issues an alert, the first question is: which product, from which batch, was applied to whom? If the answer depends on memory or on a box that was thrown away, the problem triples. A batch and traceability record is a simple form that answers that in seconds.
The template below is a control sheet for injectable products. It does not mention brand, dose or technique. For the general context, read traceability of injectables.
When should you use this template?
At every application, at the time of the procedure. Stick the label in the patient's record and also log it in the clinic's general sheet (by product), which lets you quickly cross-check who received that batch. Check the data before opening the product, not after.
How do you adapt it?
- Record by patient and by product: date, product, manufacturer, registration number, batch, expiry and quantity used, according to the clinic's routine.
- Check the product's registration with ANVISA (Brazil's health regulatory agency) before using it. See how to look up an injectable's registration with ANVISA.
- Keep the box or the invoice of the product, with the batch and supplier. Always ask for an invoice (nota fiscal).
- Standardize where the label goes: always in the same field of the record.
- Record the disposal of leftovers, according to the clinic's waste plan.
- Keep inventory control with the same logic: entries, exits and expiry dates. See injectable inventory at the facial harmonization clinic.
- Train the team not to skip the step when the day is busy.
What can never be missing?
| Item | Reason |
|---|---|
| Date and professional | Places the application in time |
| Patient identification | Links the product to the case |
| Product name, manufacturer and registration | Identifies what was used |
| Batch and expiry | The central piece of traceability data |
| Quantity used | Inventory control and the case |
| Area treated | Gives context to the event |
| Supplier and invoice | Origin of the product |
| Event and report field | Adverse event |
Batch record and traceability template
What if there is an adverse event?
Care for the patient first. Then gather the product, batch and progression data, record it in the patient record and assess reporting to ANVISA through the Notivisa system (see adverse event reporting (Notivisa) and the official ANVISA page). If necessary, notify the manufacturer and the supplier. For the case of an unknown product in a patient arriving from another provider, see patient with unknown previous filler. For the general organization of the room and materials, use the procedure room checklist and protect the data in line with the LGPD.
Frequently asked questions
Why record the batch of the product applied to the patient?
Because it lets you know exactly which product was used on each patient. In an adverse event, a recall or a doubt about the product, the batch links the case to the manufacturer and the supplier. It is the basis of traceability.
How do I report an adverse event of an aesthetic product to ANVISA?
Through ANVISA's notification system (Notivisa), Brazil's health regulatory agency, with the product, batch and event details. Follow your professional council's rules and confirm the current procedure on the ANVISA website. Well-recorded traceability makes this report easier.
Can I stick the product label in the patient's record?
Yes, it is a common and useful practice: the label with name, batch and expiry goes in the patient record along with the procedure date. If the product has no peel-off label, write the data by hand.