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

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Overview

Sheet1
Introduction
Contact Information
Person Affected
Problem Summary
Test Pop-Up
Suspect Product Details
Suspect Product Pop-Up
Ingredient Pop-Up
Concomitant Product Details
Notice
Attachments
Attachments Pop-Up

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Sheet 1: Sheet1

Draft Foods RQ for FDA Safety Reporting Portal

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Sheet 2: Introduction

Welcome Guest

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Name:

Food Report

Introduction

ID:

36730 (I)

Created:

7/1/2015

* = Required

• Introduction

You have chosen to use this electronic portal to submit a voluntary report to FDA about an adverse event associated with a cosmetic

• Contact Information

product (adverse health-related event, such as an illness or injury) and/or a product problem with a cosmetic product.

• Person Affected

• Problem Summary

Please be advised that under 18 U.S.C. 1001, anyone making a materially false, fictitious or fraudulent statement to the U.S. Government

• Suspect Product Details

is subject to criminal penalties.

• Attachments

This report has up to 4 sections. After you answer the questions on this page, you may complete the other pages in any order. The

OMB Approval

amount of time required to complete this report will vary depending on the information you have to provide. As you complete each page,

Number:

0910-0645

your responses are automatically saved. To submit this report, you must complete all required fields that are marked with a red asterisk.

OMB Expiration

Instructions for completing the MedWatch 3500 form, on which this report is based, can be found here.

Date:

4/30/2016

OMB Burden Statement

Report Identifying Information

* Please enter a title to help you identify this report.

* What type of report are you submitting?

Adverse event (an adverse health-related event

associated with the product)

Product Problem (e.g., defects in the quality or safety of

a product)

Both

* What kind of product do you need to report about?

Dietary Supplement

Food

Cosmetic

Infant Formula

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Sheet 3: Contact Information

Welcome Guest

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FAQS

RELATED LINKS

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FEEDBACK

HELP

Name:

Foods Report

Contact Information

ID:

36730 (I)

Created:

7/1/2015

* = Required

• Introduction

Affected Individual Information

• Contact Information

• Person Affected

Do you wish to remain anonymous to the FDA?

No

• Problem Summary

• Suspect Product Details

First Name

• Attachments

Last Name

OMB Approval

Number:

0910-0645

Email

OMB Expiration

Confirm Email

Date:

4/30/2016

OMB Burden Statement

Phone

Country

Please select

V

Street address line 1

Street address line 2

City/Town

State

Please select

V

Mail/Zip Code

Have you reported the event to the company on the label?

Manufacturer

Distributor

Packer

Are you a healthcare professional?

Yes

No

Healthcare professional type

Please select

V

<--- Dependent on previous question

If other, please describe

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Sheet 4: Person Affected

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Name:

Foods Report

Person Affected

ID:

36730 (I)

Created:

7/1/2015

* = Required

• Introduction

Affected Individual Information

• Contact Information

• Person Affected

Person's Initials

• Problem Summary

• Suspect Product Details

Gender

Male

Female

• Attachments

Age at time of event, if unknown, please enter Date

Select unit of measure

V

OMB Approval

of birth below

Number:

0910-0645

Date of birth

OMB Expiration

Date:

4/30/2016

Weight

Select unit of measure

V

OMB Burden Statement

Race

Select one

V

Diagnosed allergies (select all that apply)

Allergy X

Allergy Y

Parent Allergy Z

Child Allergy Z1

Child Allergy Z2

Relevant medical history

^

v

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Sheet 5: Problem Summary

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Name:

Foods Report

Problem Summary

ID:

36730 (I)

Created:

7/1/2015

Adverse Event and/ or Product Problem Description

• Introduction

• Contact Information

Date of adverse event

• Person Affected

• Problem Summary

Duration of adverse event

Select unit of measure

V

• Suspect Product Details

• Attachments

How soon did the symptoms develop after using the product?

Select unit of measure

V

OMB Approval

* Outcomes attributed to adverse event (check all that apply)

Hospitalization

Number:

0910-0645

Disability/health problem

OMB Expiration

Life-threathening (ex. breathing difficulties, anaphylactice shock, etc.)

Date:

4/30/2016

Death

OMB Burden Statement

Date of Death

If other, please describe:

Please select any of the symptoms below that you experienced as a result of this event:

Diarrhoea

Choking

Malaise

Dizziness

Vomiting

Abdominal Pain

Dysponea (shortness of breath)

Rash

Nausea

Headache

Dysphagia (difficulty swallowing)

Pain

How soon did symptoms develop after using the product?

Select unit of measure

V

* Please provide details about the event or problem

Do you suspect certain ingredients in the product may have been the cause of the adverse event?

Yes

No

Which ingredient(s)?

Was the adverse event/problem resolved?

Yes

No

Did all of the symptoms go away?

Yes

No

If so, how and when was it resolved?

Date of lab test

Lab Test Name

Test Result(s)

Click on the Add button to add an item

Add

Edit

Delete

Attention

At the end of this report you will be asked to provide attachments including photos relevant to this case. Being able to correctly identify the product in your

case is very important to us. We ask that you please submit photos of all sides of your product (including the ingredients label and lot number).

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Adverse Event Term(s)

Click on the Add button to add an item

Add

Edit

Delete

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Sheet 6: Test Pop-Up

Relevant Test/ Laboratory Data

Please provide any relevent lab test results. Consider attaching your lab documentation to this report, which you can do in the final section.

*Lab test name

Please select

V

Date of lab test

Test Results

Save

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Sheet 7: Suspect Product Details

Welcome Guest

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HELP

Name:

Cosmetics Report

Suspect Product(s) Details

ID:

36730 (I)

Created:

7/1/2015

* = Required

• Introduction

For adverse event reporting, a suspect product is one that you, the reporter, suspect was associated with the adverse event.

• Contact Information

• Person Affected

• Problem Summary

* Product Details

• Suspect Product Details

Name

Manufacturer/distributor/packer

UOM

• Attachments

Click on the Add button to add an item

Add

Edit

Delete

OMB Approval

Number:

0910-0645

Product Ingredients

Ingredient

Amount

UOM

Click on the Add button to add an item

OMB Expiration

Add

Edit

Delete

Date:

4/30/2016

OMB Burden Statement

Exit

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Sheet 8: Suspect Product Pop-Up

Suspect Product Details

Please start typing the brand or name of the product in the "Select 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 box menu below. If your product is not

displayed, please choose "other".

* Select full name of product as it appears on the package

label

* Do you need to change any of the pre-filled product

Yes

No

information below?

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

Product manufacturer, packer, distributor

UPC Code

Expiration/use-by date

Lot number

Is this a medical food?

Yes

No

Diagnosis or Reason for Use

<--- Display based on "Is this a medical food?"

Product Usage

Dates of product use (estimate if necessary) if dates are

unknown, please estimate duration of use below. Start:

End:

Duration of product use

Select unit of measure

V

Frequency of usage

Select unit of measure

V

Amount consumed per serving

Select unit of measure

V

How was the product prepared?

V

Did the problem stop after reduced does or usage?

Yes

No

Did the problem return if product was used again?

Yes

No

Additional Notes Describing Product Usage

Save

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Sheet 9: Ingredient Pop-Up

Suspect Product Ingredient

Ingredient

Please select

Ingredient Amount

Save

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Sheet 10: Concomitant Product Details

Welcome Guest

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CONTACT US

FEEDBACK

HELP

Name:

Cosmetics Report

Concomitant Product(s) Details

ID:

36730 (I)

Created:

7/1/2015

* = Required

• Introduction

For adverse event reporting, a suspect product is one that you, the reporter, suspect was associated with the adverse event.

• Contact Information

• Person Affected

• Problem Summary

* Product Details

• Suspect Product Details

Name

Manufacturer/distributor/packer

UOM

• Concomitant Product Details

Click on the Add button to add an item

• Attachments

Add

Edit

Delete

OMB Approval

Number:

0910-0645

Product Ingredients

Ingredient

Amount

UOM

OMB Expiration

Click on the Add button to add an item

Date:

4/30/2016

Add

Edit

Delete

OMB Burden Statement

Exit

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No Concomitant products for foods reports

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Sheet 11: Notice

Welcome Guest

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FAQS

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HELP

Name:

Cosmetics Report

Important Notice

ID:

36730 (I)

Created:

7/1/2015

Attention

• Introduction

You have now reached the end of this report. On the next page you will be asked to provide attachments, including photos relevant

• Person Affected

to this case. Being able to correctly identify the product in your case is very important to us. We ask that you please submit photos

• Product(s) Details

of all sides of your product (including the ingredients label and lot number). Additionally, please submit any other relevant attachments

• Problem Summary

(including laboratory/medical examinations, photo of your reaction, etc.).

• Contact Information

• Attachments

Please click Next to proceed to the Attachments section of the report.

OMB Approval

Number:

0910-0645

OMB Expiration

Date:

4/30/2016

OMB Burden Statement

Exit

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Sheet 12: Attachments

Welcome Guest

HOME

FAQS

RELATED LINKS

CONTACT US

FEEDBACK

HELP

Name:

Cosmetics Report

Attachments

ID:

36730 (I)

Created:

7/1/2015

* = Required

• Introduction

You may upload up to 5 (10 MB each) attachments per submission. The following file extensions are permitted:

• Contact Information

.doc, .docx, .pdf, .gif, .jpg, .jpeg, .png, .tif, .tiff, .txt, .rtf, .xls, .xlsx, .wpd

• Person Affected

• Problem Summary

• Suspect Product Details

File Name

Type

Description

• Concomitant Product Details

Click on the Add button to add an item

• Attachments

Add

Edit

Delete

OMB Approval

Number:

0910-0645

OMB Expiration

Date:

4/30/2016

OMB Burden Statement

Exit

Submit Report

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Sheet 13: Attachments Pop-Up

Relevant Test/ Laboratory Data

*File to attach

Browse

* Description of Attachment

* Type of Attachment

Please select

V

Save

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