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

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The Safety Reporting Portal

Begin Reporting Here
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
· Tobocca 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 andlor 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 toed facility or responsible party that manufactures, processes, packs, or holds toed who is submitting a reportable food report.

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A veterinarian or veterinary staff member v.ho 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 a tobacco product
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A dietary supplement manufacturer, packer, or distributor who is submitting a mandatory serious ad·1erse 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, cr distributor who is submitting a voluntary adverse event and/or product problem report.

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10/10/Z01Z oq:z4 :41 AM

357Z (I)

creatine

Mandatory Dietary Supplement Report

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QqfWZ01Z 08:4 5:33 AM

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Whey Supplement

Mandatory Dietary Supplement Report

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Protein Treats

Mandatory Dietary Supplement Report

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Mandatory Dietary Supplement Report

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WelcomeD. Manufacturer

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Introduction
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Introduction
=Required

You have chosen to use this portal to submit a mandatory serious adverse event report about a dietary supplement to the FDA, as required
under section 761 o f the Federal Food, Drug, and Cosmetic Act (FD&C Act) (Z1 U.S.C. 37qaa·1). Manufacturers, packers, or distributors of
dietary supplements whose names appear on the label of a dietary supplement marketed in the United States are required to submit to FDA
on the MedWatch form (3500A) any report received of a serious adverse event associated with such dietary supplement when used in the
United States, accompanied by a copy of the label on or within the reta~ packaging of such dietary supplement. Serious adverse event
reports received through the address or phone number on the label of a dietary supplement, as well as all follow· up reports of new medicol
information received by the responsible person within one year after the initial report, must be submitted to FDA no later t~an 15 business days
after the report is received by the responsible person.

My Report History
OMS~

NUT!>ec.

oq10·064S

OMS Expfo!Xn
0113112013
Dote:

FDA has made available, for those who choose to use it, this method of electronic submission for mandatory serious adverse event reports
about a dietary sup~lement. FDA will accept reports filed via this portcl to satisfy firms' statutory reporting duty under section 761 of the
FD&C Act and intends to exercise enforcement discretion for firms' faillre to use the paper MedWatch form 3500A required by that section,
provided that the responsible person has completed all required fields in and submitted this electronic form. Use of this electronic form (which
contains some new mandatory questions) is completely voluntary and the paper MedWatch form 3500A will continue to be accepted until FDA
conducts rulemaking to require use of an electronic form for mandatory reports. Instructions for completing the MedWatch 3500A form, on
which this report is based, can be found here link to: httg:l/www.fda.gov/Safety/MedWatch/HowToRegort/DownloadForms/ucm14qz38.htm,
and instructions specific to using the MedWatch 3500A form for mandatory dietary supplement serious adverse event reports can be found
here link to: httg://www.fda.gov/Food/GuidanceCo!!J21ianceRegulatorylnformation/GuidanceDocuments/DietarvSugglementslucm171415.htm
Additionally, FDA has published industry guidance for submitting dietary supplement serious adverse event reports. This document can be found
here link to: httg://www.fda.gov/tood/guidanceco[!lllianceregulatoryjnformation/guidancedocuments/dietarysugglements/ucm171383.htm.

IReport Information

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Please enter a title to help you identify this report.
Consider using your firm's internal case tracking number for
simplified recordkeeping.

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•What type of report are you submitting?

Serious adverse event (a serious adverse health·related event

associated with the product)

0

Serious adverse event and product problem (e.g., defects that may

have caused or contributed to a serious adverse event)

•Enter the date yOl received the initial report:
How did the initial reporter learn of the
serious adverse e'lent or product problem?
(check all that apply)

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0
0
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0

It other, please describe

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Consumer
Friend or Relative
Distributor
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Submit Report

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WelcomeD. Manufacturer

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Introduction
Introduction

• =Required

Contact Information

You have chosen to use this portal to submit a mandatory serious adverse event report about a dietary supplement to the FDA, as required
under section 761 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (Z1 U.S.C. 37qaa·1). Manufacturers, packers, or distributors of
dietary supplements whose names appear on the label of a dietary supplement marketed in the United States are required to submit to FDA
on the MedWatch form (3500A) any report received of a serious adverse event associated with such dietary supplement when used in the
United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement. Serious adverse event
reports received through the address or phone number on the label of a dietary supplement, as well as all follow· up reports of new medical
information received by the responsible person within one year after the initial report, must be submitted to FDA no later than 15 business days
after the report is received by the responsible person.

Problem Summary
Products
Concomitant Products
Attachments
My Report History

FDA has made available, for those who choose to use it, this method of electronic submission for mandatory serious adverse event reports
about a dietary supplement.. FDA will accept reports filed via this portal to satisfy firms' statutory reporting duty under section 761 of the
FD&C Act and intends to exercise enforcement discretion for firms' failure to use the paper MedWatch form 3500A required by that section,
provided that the responsible person has completed all required fields in and submitted this electronic form. Use of this electronic form (which
contains some new mandatory questions) is completely voluntary and the paper MedWatch form 3500A will continue to be accepted until FDA
conducts rulemaking to require use of an electronic form for mandatory reports. Instructions for completing the IMedWatch 3500A form, on
which this report is bosed, can be found here link to: httg:l/www.fda.gov/Satety/MedWatch/HowToRegort/DownloadForms/ucm14qz38.htm,
and instructions specific to using the MedWatch 3500A form for mandatory dietary supplement serious adverse event reports can be found
here link to: httg://www .fda.gov/Food/GuidanceCo~lianceRegulatorylntormation/GuidanceDocuments/Dietarl§ugglementslucm171415.htm
Additionally, FDA has published industry guidance for submitting dietary supplement serious adverse event reports. This document can be found
here link to: httg:/lwww .fda.govltoodlguidanceco~Iianceregulator)lintormationlguidancedocumentsldietary:sugglementslucm171383.htm.

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Report Information

Please enter a title to help you identify this report.
Consider using your firm's internal case tracking number
for simplified recordkeeping.

.

I

I

0

What type of report are you submitting?

Serious adverse event (a serious adverse health·related event

associated with the product)

0

.

Enter the date you received the initial report:

It other, please describe

Orignal ICSR number

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0
0
0
0
0
0

Lawyer
Social Media
Other

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Z354363463

Reason for follow·up

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Distributor
Health Professional

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Consumer
Friend or Relative

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Initial report date

Save Draft

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How did the initial reporter learn of the
serious adverse event or product problem?
(check all that apply)

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Serious adverse event and product problem (e.g., defects that may

have caused or contributed to a serious adverse event)

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Submit Report

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03/ 01 /Z013

Read·only fields pre-populated with the original SRP
report submission information

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Horufoctw er, Po cker, or Oiltributor Site Information
ProbkHn S~.mmary
Prod.Jcts
Concomitant Prodx:ts
Attoctments

My ac00111t odct"esa • tiM! sane as tiM! rna"Y.Jfoct~er. packer, or

Wek:ome D. Mooufact\rer

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Contact Information
Problem Summary

Affected Individual Information

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Products

(i)

Attachments
My Report Hstory

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Gender

0

Age at time of event, if ooknown, please enter
Dote of birth below

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Mole

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0~0-0645

Weight

OMBExj:totX:n
Dote:
011'3112013

Female

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Dote of brt'

0MBAf¥cW

Provide the potient' s initials or
some other type of ident ifier that
wi• allow both the subnltter and the
n it iol reporter (if afferent) to
locate the case if contacted for
folow·up. Do not use the p >I

Add

Hepatitis B virus

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Edjt

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Please pro\'ide relevoot medcal history, incluOOg pre·existing condtions (e.g., olergie s, race, pregnoocy, smoking ood alcohol
use, Wer/kki1ey problems, e tc.) ·

¢
Do you hove ooy relevoot testslloborotory data information to report ?

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O No

Yes

Relevoot T ests/Loborotory Data
Dote of lob test

Lob test nome

Dote of lob test

T e st result(s)

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CBC

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Test rerut(s)
~WBC

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Adverse Event Terms
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Please start typing t~.e 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 ahead oontrol with "Other' option always avalable

.......

al

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valium

--·
-----------Other

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

Relevant Testsllab Data
Lab test name

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It other, please describe

1~::::;-:;::;---------ll

Date of lab test

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Test result(s)

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Suspect Product{s)

Introduction

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Contact Information

Suspect Product Details

Problem Summary
Products
Conoomitant Products

For adverse event reporting, a suspect product is one that the inrtial reporter suspected was associated wrth the adverse
event.As required by 761(b)(1) of the FD&C Act (21 U.S.C. 37qaa- 1(b)(1)) you must submrt a copy of the product label. Product
labels can be attached on the Attachments tab.

Attachments

Grid view after products are added

My Report History

Name

Manufacturerldisributorlpacker

Strength

UOM

Name

Manufacturerldisributorlpacker

Strength

UOM

OM8Ag«Nd

NUTI>ec.

oq10·064S

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Click on the Add button to add an item

OM8Expfoti:n

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FDA reoognizes the burden that oompletely filng out the folowing section may present Please note that this sub· section is
optional, and we appreciate any effort you can make to provide ingrecjent information.

Add

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ln!7edient details f o r
Ingredient Name

Amount

UOM

mg

150

ABC

Add

....,

....

'Ill

-

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Edit

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1

• I have reviewed the ingredients tisted for each product, if
available, and made any necessary oorrections

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Submit Report

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Edit

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Ingredient Name

Delete

1

I< < Page 1 of 1 > > I

Amount

UOM

mg

Ibuprofen

300

Vitamin D

zoo

g

Calcium

45

mg

Vitamin B1Z

1:0

ug

0
Add

Save Draft

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Grid view with ingredients linked to the product (pre-filed based on the product selected)

0
0
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Only asked if one or
mare products has
ingredients tisted;
othewise hidden

Joint·Ease

0113112013

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Suspect Product Details

Blue text= conditionally field

Please start typing the brand or name of the product in the •Full name of 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 menu below. If your product is not
displayed, please choose • other. •

IType to search and select

14

If other, please provide full product name

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Product manufacturer, packer, or distributor

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Product strength

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Barcode identifier

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• Full name of product as it appears on the package
label

.

If other, please describe

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Select Unit of Measure

1•1

_.
Identifier type \ • 1 -

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

-

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

Lot number

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Expirotionluse•by dote\V

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How Product Was Used

Dates of product use (estimate if necessary), if dates
are unknown, please estimate duration of use below

Start

I I I llj

Duration of product use
Frequency of consumption
Amount consumed per serving
Administration route

III

llj
I IPlease select 1•1
I ISelect Unit of Measure 1•1
I ISelect Unit of Measure 1•1
H

Please select

End

Did the event stop when product use stopped or the
amount consumed was reduced?

0

Yes

0

No

0

Unknown

Did the event reoccur when product use resumed?

0

Yes

0

No

0

Unknown

0

Not Applicable

0

Not Applicable

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Please provide any notes describing the product's usage:

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beginning and within terms
are included

UPC
Other

Diagnosis or reason for use (indication):

¢c

-

~ Auto-complete ~st based on
CFSAN supp~ed ist of
standard products

Cancel

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--.~a~
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allerest

valium
Other

Add Ingredient
Blue text = conditionally field

Ingredient details f or
Please start typing the ingredient name in the "Ingredient name" box. The form will display all of the ingredients with
that name in the drop down box menu below. It the ingredient is not displayed, please choose "other".
Ingredient name
It other, please describe
Ingredient amount

IType to search and select

r-~ Auto·complete control with "Other' option always available

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ISelect Unit of Measure H

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Save

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Cancel

...............
al
aleve

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Other

Edit Ingredient
Ingredient details for
Ingredient name

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Ingredient amount

130

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lbuprophen

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H

milligrams ( mg)

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Save

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-

Auto·comp~ete list bosed on
CFSAN supplied ~st of
standard ingredients

Partial matches at the
beginning and within terms
are included

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Contoct lnformollon
Problem Swnmcry

Concomitant Product(s)
• =R~ed

Products

Concomitant Product Details

Concomitant Produc:ts

For adverse event reportng, o suspect product is one t hat the ntiOI reporter suspected wos 0880c:l0ted wrth the adverse event.
Concomitant produc:ta ore other products that i'lc:Ude either cietay supplements, G-uge, or devoces that the offeeted ndiviO.Jol was
U8llg at the tme of the e vent but that ore NOT thouglt by t he ntiOI reporter to be nvolved n the e vent

Attoc:tments
My Report History
OMBAWO"fd

NU>i>er.

oq1o-o14s

Monufocturerldistributorlpocker

Nome

Strength

UOM

Monufocturerldistributorlpocker

Nome

Strength

UOM

OMBExpi'-Olkn
0113112.013
Daleo

0

Click on the Add button to odd on item

Add

J

Edit

I

1

Delete

I<

< Page 1 of 1 > > I

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FDA recoglizea the burden tt>ot completely fA'1g out the lolowi'lg section may present. Please note that this sub· section is
optioniOI, and we oppreciote a~y effort you COI'I moke to provide i'lg"ecient information.
l n~ ed i ent

Ortt osked rl one
or more produc:ts
has ng-eaents
isted; otheWise

...

All'lOU'lt

Edit

I

Delete

UOM

Save Draft

I

Exit

I

Edit

lngecient Nome

0

1

- • I hove reVIewed the ng-ecients lsted for each prodJct,
ovoioble, and mode any necessary correctJons

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Delete

1

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< Page 1 of 1 > > I

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Clck on the Add button to odd on item

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Add

mg

150

details for

lngecient Nome

Add

ABC

J oint·Ease

Submit Report

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~olen

Add

n

0

I

< Bock

I

Next>

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Edit

Amount
300

UOM
mg
I<< Poge1of1>

blue text = conditional field

I Product Details
Please sat typing the brand or name of the concomitant product in the 'Full name of 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 menu below.
It your product is not displayed, please choose • other. •

I

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It other, please describe

I

I

Product manufacturer, packer, distributor or
other reponsible party

I

I

Product strength

I

Barcode identifier

I

It other, please describe

II

I

Select Unit of Measure

1•1

~

1 TnnntO.. ·type

I

I

1tJ{'c Unit 2000 characters. If text exceeds 2000 characters, please attach additional documentation on the

r--- -

af!achments tab.

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

Lot number
Expiration/use-by date \Y

lttow

I

I

llij

III

I Product Was Used

Dates of product use (estimate if necessory), if dates
are unknown, please estimate duration of use below
Duration of product use

Frequency of consumption/use
Amount consumed per serving
Administration route

Start

I I I llj

I
I
I

End

II
II
II

llij

III
Please select

1•1

1•1
Select Unit of Measure 1
•1
Select Unit of Measure

IPlease select

H

Please provide any notes describing the product's usage:

I

I

~

I al
aleve
allerest

Diagnosis or reason for use (indicotion):

...

..

a

Full name of product as it appears on the package
label

I

Sove

I

Cancel

~

-

Auto-complete list bosed
on CFSAN supp~ed ist of
standard products

valium

--·
-----------Other

-

UPC
Other

Partial matches at the
beginning and within terms
are included

119'edient deloils for

Please stat t~ the ng-edent nome n the "ltvedent Nome' box. The form wil cisploy Cll cf the ilg'edents
with that nome in the drop down menu below. If you- ng-edent is not cisployed, please choose "other.'

lngedent nome
If other, please describe
Ingredient amount

I

Type to search and select

r Auto-COIT1)1ete control with 'Other' option dwoys ovoioble

""'liA

I

I

ol

I

oleve

I Select Unit of Measure H

I

Save

I

Cancel

onerest

l

-

Auto-COIT1)1ete ist based on
CFSAN supplied ist of
stondord ingredients

volium
Other

Partial matches ot the
beginning ond within terms
ore included

WelcomeD. Manufacturer

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Introduction
Contact Information
Problem Summory
Products
Concomitant Products

.

Attachments
=Required

You may upload up to 5 (10MB each) attachments per submission. The following file extensions are permitted:
.doc,.docx,.pdf,.bmp,.gif,.jpg,.jpeg,.png,.tif,.tiff,.txt,.rtf,.xls,.xlsx,.wpd.

Attachments
My Repor1 History
OM8Agro/d

Nurt>ec.

Type of Attachment

oq1o-o6's

0

Lab Results

Multiple results

01131/2013

0

Product label

photograph

OM8Expfoti:n
Dote:

File to attach

Add

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Save Draft

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

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