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

FDA Adverse Event Reports; Electronic Submissions

0645 RQ for Foods.xlsx

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

OMB: 0910-0645

Document [xlsx]
Download: xlsx | pdf

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


Sheet 1: Sheet1

Draft Foods RQ for FDA Safety Reporting Portal

Sheet 2: Introduction



Welcome Guest








HOME
FAQS
RELATED LINKS
CONTACT US
FEEDBACK
HELP


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




























































































Exit
Submit Report









< Back
Next >





















































Sheet 3: Contact Information









Welcome Guest








HOME
FAQS
RELATED LINKS
CONTACT US
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



























































































































































































Exit
Submit Report









< Back
Next >



























































Sheet 4: Person Affected



Welcome Guest








HOME
FAQS
RELATED LINKS
CONTACT US
FEEDBACK
HELP


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






















































































Exit
Submit Report









< Back
Next >
























































Sheet 5: Problem Summary



Welcome Guest












HOME
FAQS
RELATED LINKS
CONTACT US
FEEDBACK
HELP


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).
































































































Exit
Submit Report









< Back
Next >














































































































































































































































































Adverse Event Term(s)

































Click on the Add button to add an item





















Add
Edit
Delete














































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
Cancel




















Sheet 7: Suspect Product Details



Welcome Guest













HOME
FAQS
RELATED LINKS
CONTACT US
FEEDBACK
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
Submit Report









< Back
Next >






























































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
Cancel














































Sheet 9: Ingredient Pop-Up




















Suspect Product Ingredient

















































Ingredient



Please select



























Ingredient Amount




























































Save
Cancel


















Sheet 10: Concomitant Product Details



Welcome Guest













HOME
FAQS
RELATED LINKS
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
Submit Report









< Back
Next >



































































































No Concomitant products for foods reports





















Sheet 11: Notice



Welcome Guest













HOME
FAQS
RELATED LINKS
CONTACT US
FEEDBACK
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
Submit Report









< Back
Next >






























































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









< Back
Next >






























































Sheet 13: Attachments Pop-Up






















Relevant Test/ Laboratory Data























































*File to attach













Browse








































* Description of Attachment























































* Type of Attachment





Please select






V








































































Save
Cancel



















File Typeapplication/vnd.openxmlformats-officedocument.spreadsheetml.sheet
File Modified0000-00-00
File Created0000-00-00

© 2024 OMB.report | Privacy Policy