Idiomas disponibles
Idiomas disponibles
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 acknowledgment 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:
a. Report online at:
www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
b. 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
c. Call FDA at 1-800-FDA-1088 to report by telephone
Reporting Form FDA 3500 commonly used by heath professionals. The form is available at:
www.fda.gov/downloads/aboutFDA/reportmanualsforms/forms/ucm163919.pdf
FOR MEXICO ONLY
• This device is not intended for use by persons (including children) whose physical,
sensory or mental capabilities are different or reduced, or who lack experience
or knowledge, unless such persons have been given supervision or training in the
operation of the device by a person responsible for their safety.
• Children should be supervised to ensure that they do not use the devices as toys.
• The device must only be powered at the safety extra-low voltage indicated on the device.
• The device must only be used with the charger unit provided with the device.
• The battery must be removed from the device before disposal. The device must be
disconnected from the charger when the battery is removed. The battery is removed
for safe disposal.
