MedWatch
Online Voluntary Reporting Form (3500)
Why Should I Report?
The testing that helps to establish the safety of products,
such as drugs and medical devices, is typically conducted
on small groups before FDA approves the products for sale.
Some problems can remain unknown, only to be discovered when
a product is used by a large number of people.
When problems with FDA-regulated products occur, the agency
wants to know about them and has several ways for the public
to make reports. Timely reporting by consumers, health professionals,
and FDA-regulated companies allows the agency to take prompt
action. The agency evaluates each report to determine how
serious the problem is, and, if necessary, may request additional
information from the person who filed the report before taking
action.
How do I report an emergency?
If the situation is an emergency that requires
immediate action, such as a case of food-borne illness or
a drug product that has been tampered with, call the agency's
main emergency number, staffed 24 hours a day, 301-443-1240.
You also can report emergencies, as well as non-emergencies,
to the FDA consumer complaint coordinator in your geographic
area.
What products does FDA regulate?
Consumers can play an important public health
role by reporting to FDA any adverse reactions or other problems
with products the agency regulates. FDA is responsible for
ensuring that foods are safe, wholesome, and correctly labeled.
It also oversees medicines, medical devices (from bandages
to artificial hearts), blood products, vaccines, cosmetics,
veterinary drugs, animal feed, and electronic products that
emit radiation (such as microwave ovens and video monitors),
ensuring that these products are safe and effective.
How do I report non-emergencies
about medical products: medicines, medical devices, blood
products, biologics, special nutritionals?
FDA's MedWatch program allows healthcare professionals and
consumers to voluntarily report serious problems that they
suspect are associated with the drugs and medical devices
they prescribe, dispense, or use. These problems include serious
adverse reactions, product quality problems, and medical errors.
Reporting can be done online, by phone, or by submitting the
MedWatch 3500 form by mail or fax. Visit the MedWatch site
for more details.
How do I report non-emergencies
about vaccines? Adverse reactions and other
problems related to vaccines should be reported to the Vaccine
Adverse Event Reporting System, which is maintained by FDA
and the Centers for Disease Control and Prevention. For a
copy of the vaccine reporting form, call 1-800-822-7967 or
get a copy of the form from the FDA Website.
How do I report non-emergencies
about veterinary products? Report any problems
with veterinary drugs and animal feed to FDA's Center for
Veterinary Medicine at 1-888-FDA-VETS (1-888-332-8387). You
can also find the reporting form on the center's Website
How do I report non-emergencies
about products sold online? If you find a Website
you think is illegally selling human drugs, animal drugs,
medical devices, biological products, foods, dietary supplements,
or cosmetics over the Web, you may report it to FDA using
the form on this Website.
What should I include in my
report? Report what happened as soon as possible.
Give names, addresses and phone numbers of persons affected.
Include your name, address and phone number, as well as that
of the doctor or hospital if emergency treatment was provided.
State the problem clearly. Describe the product as completely
as possible, including any codes or identifying marks on the
label or container. Give the name and address of the store
where the product was purchased and the date of purchase.
You also should report the problem to the manufacturer or
distributor shown on the label and to the store where you
purchased the product
Reports should preferably include a good medical history,
all concomitant drugs the animal has been given, any recent
surgical procedures, and as much in the way of clinical findings
as is possible. Clinical findings would include veterinary
exam, clinical chemistries, complete blood counts, urinalysis,
fecal exams, radiographic results, and hemodynamic data such
as blood pressure, any other pressure measurements in or around
the heart, and neurologic assessments.
What kind of information should
be included in my complaint?Reports should preferably
include a good medical history, all concomitant drugs the
animal has been given, any recent surgical procedures, and
as much in the way of clinical findings as is possible. Clinical
findings would include veterinary exam, clinical chemistries,
complete blood counts, urinalysis, fecal exams, radiographic
results, and hemodynamic data such as blood pressure, any
other pressure measurements in or around the heart, and neurologic
assessments.
The ADE scoring system uses a modified Kramer scoring system
(Keller et al., Vet Clin North Am, Food Anim Pract, March
1999,15(1):13-30). In this system, each sign is separated
from the other signs and scored according to previous experience
with the drug, alternative etiologic candidates (other causes),
timing of the event, whether there was an overdose, whether
the reaction continued or subsided with withdrawal of the
drug, and whether a reaction recurred on re-introduction of
a drug. The scores are most accurate when there is sound clinical
information about an animal. This means that the report should
include
** a good medical history,
** all concomittent drugs the animal has been given,
** any recent surgical procedures,
** veterinary exam results,
** clinical chemistries,
** complete blood counts,
** urinalysis,
** fecal exams,
** radiographic results,
** hemodynamic data such as blood pressure, any other pressure
measurements ** in or around the heart,
** and neurologic assessments.
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