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Cosmetics Adverse Events Reporting System
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*
" indicates required fields
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2
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Notification Email (Owner)
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Fetched Email Addresses
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Company Name
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User ID
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CD Record Number
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Dropdown
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Product name text
Consumer Information
Please enter the contact information for the person who experienced the adverse event.
Consumer Name
*
Consumer Address 1
Consumer Address 2
Consumer City
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Consumer State
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Consumer Postal Code
Consumer Email
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Consumer Phone
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Consumer Date of Birth
*
Please enter the date in MM/DD/YYYY format.
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Consumer Date of Birth
*
Please enter the date in MM/DD/YYYY format.
MM slash DD slash YYYY
Sex
Please Select
Male
Female
Non-binary and/or Intersex
Decline to answer
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
Please specify gender
*
Weight
Weight Unit
Kg
Lbs
Ethnicity
Please Select
Hispanic or Latino
Not Hispanic or Latino
Race
Please Select
American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or Other Pacific Islander
White
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 the person reporting the adverse event.
Same as Consumer
Use consumer address information.
Reporter First Name
*
Reporter Last Name
*
Reporter Address 1
Reporter Address 2
Reporter City
*
Reporter State
*
Reporter Postal Code
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 Email
*
Reporter Phone
*
Are you a health professional?
Yes
No
Also sent the report to FDA?
Yes
No
Unknown
Adverse Event Information
About the Problem
(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)
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
Death
Other
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.
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When did this event occur?
*
MM slash DD slash YYYY
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Product Information
*
Product Name
Describe the event and how it happened
*
Include as many details as possible
Are you allergic to any medications, food or other products
Other diagnosed illnesses / medical history / chronic health conditions
Relevant Test/Laboratory Data
Upload Test or Lab Reports
Drop files here or
Select files
Accepted file types: jpg, jpeg, png, pdf, doc, Max. file size: 256 MB.
Product Information
Product Name
*
Brand Name
*
Product Name
*
Please Select
Triple Lipid Moisturizer
Gentle Foaming Cleanser
Daily Hydrating Facial Moisturizer
Vitamin C plus E plus Ferulic Acid Serum
Brand Name
*
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Manufacturer
Hidden
Packer
Hidden
Distributor
Do you still have the product?
*
Yes
No
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.
Hidden
Date of first use?
MM slash DD slash YYYY
Hidden
Date of last use?
MM slash DD slash YYYY
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.
Hidden
Expiration Date
MM slash DD slash YYYY
Product Identifier
Batch No.
Hidden
Serial Number
Event reappeared after reintroduction?
Yes
No
Does not apply
Retailer Information
Retailer Name
Retailer Address 1
Retailer Address 2
Retailer City
Retailer State
Retailer Postal Code
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Retailer Website
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Retailer Phone
Consumer Information
Reporter Information
Event Information
Product Information
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