Therabody TheraFace Mask Guia De Inicio Rapido página 15

Reporting adverse events to FDA
MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical
products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.
If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical
information based on your medical record that can help FDA evaluate your report.
However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health
care provider is not required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.
You will receive an acknowledgement from FDA when your report is received. Reports are reviewed by FDA staff. You will be personally contacted only if we need additional information.
Submitting Adverse Event Reports to FDA
Use one of the methods below to submit voluntary adverse event reports to the FDA:
• Report Online at www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
• Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission. For help filling out the form, see MedWatchLearn. The form is available at
www.fda.gov/downloads/aboutFDA/reportsmanualsforms/forms/ucm349464.pdf
• Call FDA at 1-800-FDA-1088 to report by telephone.
• Reporting Form FDA 3500 commonly used by health professionals. The form is available at
www.fda.gov/downloads/aboutFDA/reportmanualsforms/forms/ucm163919.pdf
FCC Caution:
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
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