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

FDA Adverse Event Reports; Electronic Submissions

0645 RQ for Infant Formula.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
Concomitant Product Pop-Up
Notice
Attachments
Attachments Pop-Up


Sheet 1: Sheet1

Draft Infant Formula RQ for FDA Safety Reporting Portal

Sheet 2: Introduction



Welcome Guest








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Name: Dietary Supp. 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.















• Concomitant Product Details























• 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








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


OMB Approval




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


Number:
0910-0645



























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

















OMB Expiration























Date:
4/30/2016


Report Identifying Information

















OMB Burden Statement





























* 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 cosmetic product)








































Both










































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




Dietary Supplement























Food























Cosmetic























Infant Formula




























































































Exit
Submit Report









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Next >





















































Sheet 3: Contact Information









Welcome Guest








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Name: Cosmetics 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



















• Concomitant Product Details

























• Attachments




Last Name














































OMB Approval




Email



















Number:
0910-0645





























Confirm Email



















OMB Expiration

























Date:
4/30/2016


Phone



















OMB Burden Statement































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 any of the following?






























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









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Sheet 4: Person Affected



Welcome Guest








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Name: Cosmetics 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









• Concomitant Product Details
























• Attachments




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









Select unit of measure



V








of birth below


















OMB Approval
























Number:
0910-0645


Date of birth












































OMB Expiration




Weight









Select unit of measure



V


Date:
4/30/2016






















OMB Burden Statement




Race



Select one



V




























































































Diagnosed allergies (select all that apply)




Allery X























Parent Allergy Y

















































Child Allergy 2























Allergy Z





































































Relevant medical history


































































^


















































v
















































































































Exit
Submit Report









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Sheet 5: Problem Summary









Welcome Guest












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Name: Cosmetics 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




























• Concomitant Product Details




























• Attachments


























































OMB Approval





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








Inpatient Hospitalization











Number:
0910-0645












Disability/health problem


























Disfigurement











OMB Expiration













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











Date:
4/30/2016











Death











OMB Burden Statement















Date of Death


























Other serious/important medical outcomes












































































































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












































































* Please describe 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)?






















































































































Did all of the symptoms go away?








Yes
No





































<--- Based on check box








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 >
































































Sheet 6: Test Pop-Up






















Relevant Test/ Laboratory Data























































*Lab test name





Please select






V



























































Date of lab test




































Test Results









































































































































































































Save
Cancel




















Sheet 7: Suspect Product Details









Welcome Guest













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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





• Concomitant Product Details













Click on the Add button to add an item














• Attachments





Add
Edit
Delete
















































































OMB Approval





























Number:
0910-0645
























































<--- Note no ingredients for IF
































OMB Expiration





























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
















<--- Free Text and Auto Fill


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
















<--- Auto Fill























Product manufacturer, packer, distributor
















<--- Auto Fill























UPC Code








































Expiration/use-by date








































Lot number








































What form is the product?
















<--- Powder, Ready to Serve, Concentrate























Is this a specialized product for something other than, or in addition too, general nutrition?

Yes
No















































Diagnosis or Reason for Use
















<--- Show/Hide based on preceding question
































































Product available for evaluation by FDA?





Yes
No



























Product Usage





























































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



















unknown, please estimate duration of use below. Start:








































End:








































Frequency of usage









Select unit of measure


V

























Amount consumed per serving









Select unit of measure


V

























What type of water was used to prepare the product?





Select one

V






<--- Tap, Bottled, Distilled, etc























Did the problem stop after reduced does or usage?





Yes
No































Did the problem return if product was used again?





Yes
No






















































































Save
Cancel














































Sheet 9: Ingredient Pop-Up









































































No Ingredients for IF


















































































































Sheet 10: Concomitant Product Details









Welcome Guest













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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


























































OMB Expiration



























<--- Note no ingredients for IF

Date:
4/30/2016



























OMB Burden Statement



































































Exit
Submit Report









< Back
Next >

































































Sheet 11: Concomitant Product Pop-Up
























Concomitant 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 specialized product for something other than, or in addition too, general nutrition?

Yes
No















































Diagnosis or Reason for Use
















<--- Based on answer to previous question

































































Product Usage





























































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



















unknown, please estimate duration of use below. Start:








































End:








































Frequency of usage









Select unit of measure


V

























Amount consumed per serving









Select unit of measure


V














































Did the problem stop after reduced does or usage?





Yes
No































Did the problem return if product was used again?





Yes
No






















































































Save
Cancel














































Sheet 12: Notice



Welcome Guest













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CONTACT US
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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
Submit Report









< Back
Next >






























































Sheet 13: 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 14: Attachments Pop-Up






















Relevant Test/ Laboratory Data























































*File to attach













Browse








































* Description of Attachment























































* Type of Attachment





Please select






V








































































Save
Cancel



















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