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Submitted URL: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=professional.reporting1
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Submission: On April 20 via manual from US — Scanned from DE
Effective URL: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
Submission: On April 20 via manual from US — Scanned from DE
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MEDWATCH ONLINE VOLUNTARY REPORTING FORM
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WELCOME
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Health professionals, consumers and patients can voluntarily report observed or
suspected adverse events for human medical products to FDA. Voluntary reporting
can help FDA identify unknown risk for approved medical products. Reporting can
be done through our online reporting portal or by downloading, completing and
then submitting FDA Form 3500 (Health Professional) or 3500B (Consumer/Patient)
to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
BEGIN ONLINE REPORT
Health Professional
(FDA Form 3500)
Consumer/Patient
(FDA Form 3500B) En español para el consumidor / paciente (formulario 3500B de
la FDA)
Continue an incomplete report
Click here to continue filling out an incomplete report. You will need Report ID
and Report Date. You will have 3 days to complete this report from the start
date.
Thank you for taking the time to submit a MedWatch report. If you wish to
download and print a copy of your report please review the MedWatch Voluntary
Report Frequently Asked Questions.
MedWatch Online now allows reporters to start a report and complete it within 3
days. Reporters can save an incomplete report and provide an email address to
receive instructions on how to complete & submit a report with Report ID and
Report Date.
INFORMATION YOU SHOULD REPORT TO MEDWATCH
* Unexpected side effects or adverse events can include everything from skin
rashes to more serious complications.
* Product quality problems such as information if a product isn't working
properly or if it has a defect.
* Product Use/Medication Errors that can be prevented. These can be caused by
various issues, including choosing the wrong product because of labels or
packaging that look alike or have similar brand or generic names. Mistakes
also can be caused by difficulty with a device due to hard-to-read controls
or displays, which may cause you to record a test result that is not correct.
* Therapeutic failures. These problems can include when a medical product does
not seem to work as well when you switch from one generic to another.
TYPES OF FDA REGULATED PRODUCTS YOU CAN REPORT THROUGH MEDWATCH
* Prescription and over-the-counter medicines including those administered in a
hospital or outpatient infusion centers.
* Biologics such as blood components, blood/plasma derivatives, blood
transfusions, gene therapies, and human cells and tissue transplants.
* Medical devices such as diabetes glucose-test kit, hearing aids, breast
pumps, and many more products.
* Combination products such as prefilled drug syringe, auto-injectors,
metered-dose inhalers, contact lens coated with a drug and nasal-spray.
* Special nutritional products such as dietary supplements, medical foods and
infant formulas.
* Cosmetics such as moisturizers, makeup, shampoos, conditioners, hair dyes and
tattoos.
* Food such as beverages and ingredients added to foods.
WHERE TO REPORT OTHER FDA REGULATED PRODUCT SAFETY INFORMATION
Other products that the FDA regulates such as Tobacco Products, Vaccines and
Animal/Livestock medicine and feed utilize different reporting pathways. It is
recommended that reports concerning these products be submitted directly to the
appropriate portals below.
* Tobacco, E-cigarettes or Vaping: Report problems or adverse health events and
tobacco product problems, include problems with e-cigarettes (also known as
"vapes"), e-liquids, heated tobacco products, cigarettes, roll-your-own
cigarettes, cigars, little cigars, pipes, waterpipes (also known as hookah),
chewing tobacco, snuff, or snus. Report issues to the Safety Reporting
Portal.
* Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System
(VAERS) online at https://vaers.hhs.gov/reportevent.html.
* Animal Drug, Device, Pet Food and Livestock Feed Problems (pet food and
livestock feed): For information on how to report visit
www.fda.gov/vetproductreporting.
Note that submissions for these products through MedWatch will be accepted and
directed to the correct center or office.
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