ADVERSE EVENT REPORT (U.S.)
ADVERSE EVENT REPORTING (USA)
IMPORTANT: This page is intended exclusively for our U.S. customers.
Your safety is important to us!
At Anakena we take the safety of our products very seriously. We carefully test all of our cosmetic products to ensure their safety and safe use. We use the most rigorous testing methods to ensure that our products meet all FDA-mandated safety standards. If you experience any adverse event related to the use of our products -acquired, particularly in the U.S.A.Please let us know immediately. Your feedback is critical to our efforts to ensure the safety and improvement of our products and, of course, the safety of our customers.
What are adverse effects?
Adverse events are negative reactions or problems that may occur following the use of a product. These include, but are not limited to
- Skin irritation
- Allergic reactions
- More serious health problems
Definition of serious adverse events
According to the FDA, a serious adverse event is one of the following:
A)
- Death or life-threatening situation
- Hospitalization
- Persistent or significant disability or incapacity
- Congenital anomalies or birth defects
- Infections
- Serious incident (including severe and persistent rash, second or third degree burns, significant hair loss, or persistent or significant change in appearance) that does not occur as expected under usual or customary conditions of use.
B)
Require, based on appropriate medical judgment, medical or surgical intervention to prevent an outcome described in (A).
If such events occur, we must report them to the FDA within 15 business days.
Notification of undesirable events
If you have detected an adverse effect, immediately send an e-mail to info@anakena-cosmetics.cl . Attach the FDA MedWatch 3500A Form which you can download here:
This form allows you to provide detailed information about the adverse event. You can also find instructions for completing the form here: Instructions for using the FDA MedWatch Form.
Our steps following your report
As soon as we have received your report, we will take the following actions:
1. Review the ReportWe will carefully review your information and follow up and analyze the details of the adverse event.
2. DocumentationIn compliance with all current FDA requirements, we will document all relevant information in our system.
3. FDA NotificationIf the adverse event is classified as serious, we are required to notify the FDA within 15 working days.
4. Follow-upDepending on the severity of the event, we may request additional information from you or communicate the results of our investigation.
Confidentiality and Data Protection
All reports will be treated confidentially and will be used exclusively to improve our products. We are committed to comply with all applicable data protection laws. These regulations ensure that your information is handled safely and responsibly, and the FDA requires us to document and report adverse events. This obligation is part of Federal Food, Drug and Cosmetics Act (Federal Food, Drug and Cosmetic Act), which ensures that consumer information on product safety is taken seriously.
Why is your message important?
Adverse event reporting helps us to improve the safety of our products and to identify and minimize potential risks to other consumers. Everyone reacts differently to cosmetic products. Although our products are rigorously tested for safety, allergic reactions can occur. Therefore, we recommend performing a "Patch Test" before using our products. Thank you for your support and trust in Anakena - Natural Cosmetics!
CONTACT US
If you have any questions or wish to report undesirable occurrences, please feel free to contact us at any time. Please contact us at:
Phone: +569 98763869
Mail: info@anakena-cosmetics.cl
