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20.Reporting adverse events
For the users/patients/customer in US
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:
1)
Report
Online
at: www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
2)
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 MedWatch
Learn
. The form is
available at: www.fda.gov/downloads/aboutFDA/reportsmanualsforms/forms/ucm349464.pdf
3)
Call FDA at 1-800-FDA-1088
to report by telephone
a)
Reporting Form FDA 3500
commonly used by health professionals. The form is available
at: www.fda.gov/downloads/aboutFDA/reportmanualsforms/forms/ucm163919.pdf
For the users/patients/customer in EU countries:
If users/patients/customer think that they or someone in they family has experienced a serious
incident that has occurred in relation to the device, users/patients/customer are encouraged to
report the incident to the manufacturer and the competent authority of the Member State in which
the users/patients/customer is established
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts(W) according to the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
