Consumer Form for filing Adverse Event
Menu
"
*
" indicates required fields
1
Consumer Details
2
Event Information
3
Product Information
4
Review and Confirm
This field is hidden when viewing the form
Notification Email (Owner)
This field is hidden when viewing the form
Fetched Email Addresses
This field is hidden when viewing the form
Company Name
This field is hidden when viewing the form
User ID
This field is hidden when viewing the form
CD Record Number
This field is hidden when viewing the form
Dropdown
This field is hidden when viewing the form
Product name text
This field is hidden when viewing the form
Multi Product name text
This field is hidden when viewing the form
Customers Age
Consumer Information
Please enter the contact information for the person who experienced the adverse event.
Consumer Name
*
Consumer Email
*
Consumer Phone
*
Consumer Address 1
Consumer Address 2
Consumer City
*
Consumer State
*
Consumer Postal Code
Consumer Date of Birth
*
Please enter the date in MM/DD/YYYY format.
Age
This field is hidden when viewing the form
Consumer Date of Birth
*
Please enter the date in MM/DD/YYYY format.
MM slash DD slash YYYY
Sex
Please Select
Male
Female
This field is hidden when viewing the form
Gender
Please Select
Cisgender man/boy (gender corresponds with birth sex)
Cisgender woman/girl (gender corresponds with birth sex)
Transgender man/trans man/ female-to-man (FTM)
Transgender woman/trans woman/male-to-female (MTF)
Decline to answer
Other gender category
This field is hidden when viewing the form
Please specify gender
*
Include as many details as possible
If other please specify
*
Include as many details as possible
Weight
Weight Unit
Lbs
Kg
Race
Please Select
American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or Other Pacific Islander
White
Ethnicity
Please Select
Hispanic or Latino
Not Hispanic or Latino
Skin Type
Please Select
Dry
Oily
Combination
Skin Reactivity
Please Select
Sensitive
Reactive
Non-Sensitive
Person reporting this information is different than the consumer above
Person reporting this information is different than the consumer above.
Reporter Information
Please enter the contact information of the person reporting this adverse event.
Same as Consumer
Use consumer address information.
Are you a health professional?
Yes
No
Also sent the report to FDA?
Yes
No
Unknown
Reporter Name
*
Reporter Email
*
Reporter Phone
*
Reporter Occupation
Please Select
Administrator/Supervisor
Biomedical Engineer
Dentist
Non-Health Professional
Nurse
Nurse Practitioner
Other Health Professional
Pharmacist
Physician
Physician Assistant
Risk Manager
Third Party Servicer
Reporter Address 1
Reporter Address 2
Reporter City
*
Reporter State
*
Reporter Postal Code
Adverse Event Information
What happened when you used the product?
(Check all that apply)
Had a bad side effect (including new or worsening symptoms)
Used a product incorrectly which could have led to a problem
Noticed a problem with the quality of the product
Did any of the following occur?
*
(Check all that apply)
Death
Life-threatening experience
Hospitalization (initial or prolonged)
Required intervention to Prevent Permanent Impairment/Damage
Significant disfigurement
Serious and persistent rashes
Second or third degree burns
Significant hair loss
Persistent or significant alteration of appearance
Congenital anomaly/Birth Defects
Infection
Other/None
Date of Demise?
*
Please enter the date in MM/DD/YYYY format.
Other
*
When did this event occur?
*
Please enter the date in MM/DD/YYYY format.
This field is hidden when viewing the form
When did this event occur?
*
MM slash DD slash YYYY
This field is hidden when viewing the form
Product Information
*
Product Name
Reaction Details
Symptoms
*
Reported Symptom
Intensity
Time of onset after applying
Duration of the issue
Was there spontaneous resolution after discontinuation?
Actions
Edit
Delete
There are no
Entries.
Add More
Maximum number of entries reached.
Describe the event and how it happened
*
Include as many details as possible
This field is hidden when viewing the form
Are you allergic to any medications, food or other products
Are you allergic to any medications, food or other products?
*
Other diagnosed illnesses/medical history/chronic health conditions/medical advice regarding adverse effect.
*
Relevant Test/Laboratory Data/Medical advice regarding adverse effect
Please upload any supporting images/files here
You can upload pictures of the symptoms
Drop files here or
Select files
Accepted file types: jpg, jpeg, png, pdf, doc, Max. file size: 256 MB.
Product Information
Brand Name
*
Product Name
*
This field is hidden when viewing the form
Brand Name
*
Product Name
*
Please Select
Triple Lipid Moisturizer
Vitamin C plus E plus Ferulic Acid Serum
Daily Hydrating Facial Moisturizer
Gentle Foaming Cleanser
Have you used any other product(s) of this brand?
Triple Lipid Moisturizer
Vitamin C plus E plus Ferulic Acid Serum
Daily Hydrating Facial Moisturizer
Gentle Foaming Cleanser
This field is hidden when viewing the form
Manufacturer
This field is hidden when viewing the form
Packer
This field is hidden when viewing the form
Distributor
Date of first use?
*
Please enter the date in MM/DD/YYYY format.
Date of last use?
*
Please enter the date in MM/DD/YYYY format.
This field is hidden when viewing the form
Date of first use?
MM slash DD slash YYYY
This field is hidden when viewing the form
Date of last use?
MM slash DD slash YYYY
Do you still have the product?
*
Yes
No
Do you have a picture of the product?
Yes
No
Front and Back of Label
*
Drop files here or
Select files
Accepted file types: jpg, jpeg, png, doc, Max. file size: 256 MB.
Is this product labeled for single use?
Yes
No
Expiration Date
Please enter the date in MM/YYYY format.
This field is hidden when viewing the form
Expiration Date
MM slash DD slash YYYY
Product Identifier
Product Batch No.
*
This field is hidden when viewing the form
Serial Number
Event reappeared after reintroduction?
*
Yes
No
Does not apply
Please add details of the area of the use?
Have you used any other cosmetic products?
Have you changed your skincare routine or skincare products in recent times?
Retailer Information
Retailer Name
Retailer Address 1
Retailer Address 2
Retailer City
Retailer State
Retailer Postal Code
This field is hidden when viewing the form
Retailer Website
This field is hidden when viewing the form
Retailer Phone
Review And Confirm
Consumer Information
Reporter Information
Event Information
Product Information
To top