62
S/N
1
2
3
4
Material name
Electric Wheelchair
Product Manual
Charger
Toolkit
Unit
Set
Number
Pcs
Pcs
Quantity
1
1
1
1
Remarks
Included battery
Including hexagon wrench,
open wrench, screw
Table 9
10. Packing list
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
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situations, you may complete the Online Reporting Form yourself.
You will receive an acknowledgement from FDA when your report is received. Reports are
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information.
Submitting Adverse Event Reports to FDA 6 of 16 Use one of the methods below to submit
voluntary adverse event reports to the FDA:
Report Online at https://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.
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/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
11.Report serious event to FDA
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