Voluntary Adverse Event Reporting via the SRP (other than RFR reports)

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The Safety Reporting Portal

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The Safety Reporting Portal (SRP) streamlines the
process of reporting product safety issues to the
Food & Drug Administration (FDA) and the National
Institutes of Health (NIH).
Whatever your role, (manufacturer, health care
professional, researcher, public health official, or
concerned citizen), when you submit a safety report
through this Portal, you make a vital contribution to
the safety of America's food supply, medicines, and
other products that touch us all.

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Who Should Submit a Safety Report?
Organizations and people in certain professional roles, such as the following,
may be required by law to submit safety reports under some circumstances.
·Food Manufacturers, Processors, Packers, and Holders
·Researchers
·Drug Manufacturers
·Dietary supplement manufacturers, packers, and distributors

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Reports You Can Submit Through this Portal
FDA safety issues involving:
·Human or animal reportable foods
·Animal drugs
·Pet foods
·Tobacco Products
·Dietary Supplements

Others, including concerned citizens, health professionals, and public
health officials, may voluntarily submit reports if they encounter
safety issues with a product and/or unanticipated harmful
effects that they believe are related to a product.

·NIH gene-transfer research

Learn more about mandatory and voluntary reporting

For other issues, find out where to submit your report.

NIH safety issues involving:

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A food facility or responsible party that manufactures, processes, packs, or holds food who is submitting a reportable food report.

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A federal, state, or local public health official who is submitting a reportable food report involving human and/or animal food

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A veterinarian or veterinary staff member who is submitting a product problem and/or adverse event report involving pet food

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A consumer or concerned citizen who is submitting a product problem and/or adverse event report involving pet food

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A marketing authorization holder (mcnufacturer) for an animal drug who is submitting a product problem and/or an adverse event.

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A clinical trial primary investigator or researcher who needs to report an adverse event involving a gene research study.

A healthcore professional submitting a product problem and/or adverse event report involving a tobacco product
A consumer or concerned citizen who is submitting a product problem and/or adverse event report involving a tobacco product

A dietary supplement manufacturer, packer, or distributor who is submitting a mandatory serious adverse event report.
A consumer, concerned citizen, or healthcore professional who is submitting a report about an illness or injury associated with dietary supplement(s),

or a dietary supplement manufacturer, packer, or distributor who is submitting a voluntary adverse event and/or product problem report.

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OMS Expfo!Xn

DoW.

01131/2013

Submitted Reports Available for Follow-Up
Submitted as of
(mm/dd/yyyy)

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Submitted Reports

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ReportJO

JCSR#

Title

I Reset \

Type

01/17/Z01Z 05:3q:41 PM

U 4 5 (I)

1Z00716 (I)

Protein Treats

Voluntary Dietary Supplement Report

5/Z5/Z01Z oq:4 5:33 AM

ZSOO (F)

1Z55Z4 5 (F)

Flaxseeds

Voluntary Dietary Supplement Report

Stcrt Follow·Up Report

Search

Click cobnn header to sort the cobnn

Dote Submitted (EST)

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ICSR Ntmber (please enter the
runber orly) :

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Welcome UserName

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Introduction

Introduction
Contact

' vu·~· ' Sumi. IOI'

Othe r vvoo~" "'u"' P•oduct•

~eport History

• =Required

You have chosen to use this electronic portal to submit o voluntary report to FDA about an adverse event associated with a dietary
supplement (an adverse health-related event, such as on illness or injury) and/or a product problem with a dietary SIJpplement.
Please be advised that under 18 U.S.C. 1001, anyone making a materially false, fictitious or fraudulent statement to the U.S. Government is
subject to criminal penalties.
This report has up to 5 sections. After you answer the questions on this page, you may complete the other pages in any order. The
amount of time required to complete this report will vary depending on the information you have to provide. As you complete each page,
your responses are automatically saved. To submit this report, you must complete all required fields that are marked with a red asterisk.
Instructions tor completing the MedWatch 3500 form, on which this report is based, can be found here link to:
httg://www.tda.gov/Satety/MedWatch/HowToRegort/DcwnloaoForms/ucm14q2.36.htm.

IReport

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Please enter a title to help you identity this report

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•What type of report are you submitting?

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Adverse event (an adverse health-related event

associated with the product)

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Product problem (e.g., detects that may have ccused or

contributed to an adverse event)

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Orignal ICSR number

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• Reason tor follow-up
Exit

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Submit Report

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02./13 I 2.013

..

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12.12.412.41414

Initial report date

I Save Draft I

Both

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....--Read-only fields pre-populated with data about the
original SRP submission

Welcome UserName

Home

FAQs

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blue text = conditional field

Logout

Introduction
Introduction
Contact Information
Problem Summary
Products
Other Concomitant Products
Attachments
My Report History

•

:RQquirQd

You have chosen to use this electronic portal to submit a voluntary report to FDA about an adverse event associated with a dietary
supplement (an adverse health-related event, such as an illness or injury) and/or a product problem with a dietary supplement.
Please be advised that under 18 U.S.C. 1001, anyone making a materially false, fictitious or fraudulent statement to the U.S.
Government is subject to criminal penalties.
This report has up to 5 sections. After you answer the questions on this page, you may complete the other pages in any order. The
amount of time required to complete this report will vary depending on the informotion you have to provide. As you complete each
page, your responses are automatically saved. To submit this report, you must ocmplete all required fields that are marked with a
red asterisk.
Instructions for completing the MedWatch 3500 form, on which this report is based, can be found here link to:
htt!2://www.fda.gov/Safety/MedWatch/HowToRe!2ort/DownloadForms/ucm14ql36.htm.

Report Information

Please enter a title to help you identify this report.

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• What type ol report are you submitting?

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Adverse event (an adverse health-related event

associated with the product)

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Product problem (e.g., defects that may have caused or

contributed to an adverse event)

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Save Draft

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Exit

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Submit Report

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Botn

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Welcome UserName

Home

Related Links

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Contact Us

Feedback

Help

Logout

blue text = conditional field

Contact Information
Introduction

•

Contact Information
Problem Summary
Products
Other Concomitant Products

=Required

'I Y0<1 Contact Information
Do you wish to remain anonymous to the FDA?

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First name

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Attachments
Last name

My Report History
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0113112013

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Yes

No

-...

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Email
Confirm email
Phone

1 lf_y~ hide "First Name" through "Postal code"

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Country

IPlease select

Street address line 1

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Z

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Street address line
City/Town
State
State/Province
MaiVZip code
Postal code

IPlease select

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Are you a healthcore professional?

If other, please describe

I Sove Draft I Exit I Submit Report ~

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Have you reported the event to any of the following? :

Healthcore professional type

H

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Distributor

g'

Packer

Yes

IPlease select
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Manufacturer

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No

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Physician
Physician Assistant
Nurse Practitioner
Nurse
Pharmacist
Other

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Home

Welcome UserNome
~roo1em

Introduction
Contact Information

Attachments

b~e

L09oot

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Provide the patient's initials or
some other type of identifier thock

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Patient identifer

Other Concomitant Products

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Adverse Event Terms
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Please start typing the term name in the • Adverse event term' box. The form will display all of the terms with
that name in the drop down menu below. It your term is not displayed, please choose •other.•

• Adverse event term

It other, please describe

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Type to search and select

Type ahead control with "Other' option always available

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Other

Type ahead will find partial
string matches.
For example, when a user
types "ai" words that start
with ai as well as words that
contain ai, will be provided in
the list of matches.

Relevant Testsllab Data
Lab test name
It other, please describe

Date of lab test
Result

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FDA recogniZes the burden that completely talg out the r - g section moy present. Please note uootthla sub· section Is
optional, ond we appreciate ony effort you con moke to provide ilgredient i'lformotion.

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Grid view with ingredients li'lked to the product (pre-filed based on the product selected)

Ingredient details for
Ingredient Nome

Amount

Ingredient Nome

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Suspect Product DetailS

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For adverse ev ent r eporting, o suspect prodtJct is one that you suspect was 0880Cioted with the adverse e v ent.
Please start typing the brand or nome of the prodtJct in the "Suspect prodtJct nome• box. The form wil display ol of the
prodtJcts with that nome or brand in the crop clown box menu below. If your prodtJct is not displayed, please choose
•other".

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IType to search ond select

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ProdtJct morufocll..rer, pocker, tion

Amo<.nt consumed per servilg
Administration route

Did the event stop when prodtJct use stopped or the

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Lmtt 2000 characters. If text exceeds 2000 characters, please attach oddltmol documentatiOn
on the attachments tab.

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Please choose the
lost day of the
calendar month if
no day IS spec1fH!d
on the prodtJct

! Identifier type

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Ingredient amount

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standcrd ingredents

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Joint·Ease

150

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FDA recog1izes the burden that completely filng out the folowing section may present. Pleose note that this sub· section is
optional, a>d we appreciate a>y effort you can make to provide ingre(jent information.

Add

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Edit

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Delete

1

I< < Page 1 of 1 > >I

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Ingre dient details f o r
Ingredient Name

Amount

UOM

Ingredient Name

Click on the Add button to add an item
Add
Only asked if one
or mare products
has ingredients
~sted; othewise

+-

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Edit

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Delete

1

• I have reviewed the ingredients listed for each product, if
ava~able, and made any necessary corrections

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Save Draft

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Exit

Submit Report

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300

Ibuprofen

Add

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Amount

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mg

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Other

Concom~ant

Product Details

blue text

= conditional field

Please start typing the brand or name of the product in the "Full name of other concomtant product as it appears on
the package label" box. The form will display all of the products with that name or brand in the drop down box menu
below. It your product is not displayed, please choose "other".

Full name of other concomitant product as it appears
on the package label
It other, please describe
Product manufacturer, packer, distributor or other
responsible party
Product strength

Barcode identifier
It other, please describe

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Type to search and select

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Select unit of measure

Identifier type

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volium

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--·
-----------Other

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Diagnosis or reason for use (indication):

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ABV

Please choose the
last day of the
calendar month if
no day is specified
on the product

-

Limit 2000 characters. If text exceeds 2000 characters, please attach additional documentation
on the attachments tab.

Lot number

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Expiration/use-by dat:f!J

III

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How Other Concom~ant Product Was Used
Dates ot product use (e stimate if necessory), if dates
are unknown, please e stimate duration ot use below

Start

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Duration ot product use

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Frequency ot consumption/use
Amount consumed per serving
Administration route

Please select

End

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Select unit ot measure 1•1
Select unit of measure 1•1
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Select unit of measure

Please provide any notes describing the product's usage:

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Auto·camplete list based
on CFSAN supp~ed ist of
standard products

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UPC
Other

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Partial matches at the
beginning and within terms
are included

title text = oonctt.Jonol fiekl

fl9'edient deloils for
Please stat typ119 the nwedent nome n the "Jng-edent Nome· box. The form will cispkly o1 of the ilg'edents
with thot nomen the G-op down menu below. If you: ngredent is not dsploye d, please choose "other."

lngredent nome

If other, please describe

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Type to search ond select

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Auto-complete control with ' Other' option ohec.

Add

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Edit

Save Draft

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Delete

Exit

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Description of Attachment
Lab results for affected person
Picture of product label

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Submit Report

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File Typeapplication/pdfFile Modified0000-00-00File Created0000-00-00