Pharmacovigilance — Adverse event reporting
Reporting adverse events is the most important safety mechanism for medical aesthetics. If you suspect that a Koretreat product caused or contributed to an unexpected reaction, please report it — even if you are uncertain.
When to report
Report any unexpected, undesired or serious event temporally associated with a BiViDerma injection: persistent swelling, vascular occlusion, nodules, infection, granuloma, hypersensitivity, biofilm, migration, or any event requiring medical or surgical intervention. Report cosmetically unsatisfactory results only if they appear linked to a product fault.
How to report (fastest first)
1. Clinical hotline 24/7: +593 988 089 010 — for acute or vascular events, call before anything else. 2. Email: farmacovigilancia@koretreat.com — for non-urgent reports. 3. The form below — for documented reports including photos and lot numbers.
What to include
Patient initials and age, product code and lot number, date of injection and date of event, treated area, technique (needle / cannula), volume injected, description of the event, action taken, current status, your name and clinic.
Confidentiality
We treat reports confidentially. Patient identifying information is handled per the Privacy Policy and the LOPDP. Reports are stored in our regulated pharmacovigilance log; access is restricted to designated personnel.
What happens next
1. We acknowledge receipt within 24 hours. 2. Our pharmacovigilance officer triages by severity. 3. Where required by ARCSA Resolución ARCSA-DE-067-2023, we file the regulatory notification on your behalf within the legal deadline. 4. We follow up with the manufacturer if a product-quality issue is suspected.
Pharmacovigilance officer
[TODO: insert name and contact] — qualified person responsible for pharmacovigilance under Ecuadorian regulations.
Submit a written report
Use this form for non-urgent documented reports. For acute or vascular events, call the hotline first.
Suspected adverse event? Call +593 988 089 010 (24/7) or email farmacovigilancia@koretreat.com.