Cosmetic Serious Adverse Event Report

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Generate an FDA 3500A serious adverse event report for a cosmetic product, compliant with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For use by cosmetic responsible persons - the manufacturer, packer, or distributor named on the product label.

ⓘ MoCRA deadline: report within 15 business days of becoming aware of a serious adverse event.

What is a "serious" event under MoCRA? Death, life-threatening experience, hospitalization, persistent or significant disability or incapacity, congenital anomaly, significant disfigurement (including serious or persistent rash, 2nd/3rd-degree burn, significant hair loss, persistent alteration of appearance), or any event requiring medical/surgical intervention to prevent these outcomes. Non-serious events are not subject to mandatory FDA reporting but must be retained in your internal records.

A. Patient Information

Use an anonymized patient code (e.g. PT001 or initials) - do not submit identifying information unless legally permitted.

A.1 Patient Identifier Anonymized code used to track follow-up.

A.3 Sex

Male Female

A.2 Age (number)

Age Unit

Years Months Weeks Days

or Date of Birth

B. Adverse Event

For cosmetic SAEs, check "Adverse Event" as the type. Below, select all MoCRA-specific seriousness criteria that apply.

B.1 Type of Report

Adverse Event (default for cosmetic SAEs) Product Problem (defects/contamination)

B.2 Outcome - MoCRA Seriousness Criteria

Select all that apply. At least one must be checked for an event to qualify as "serious" under MoCRA.

Death Patient died, and the event may have contributed. Life-threatening Patient was at substantial risk of dying at the time of the event. Hospitalization (initial or prolonged) Inpatient admission, or extension of an existing inpatient stay. Persistent or significant disability or incapacity Substantial disruption of the ability to conduct normal life functions. Congenital anomaly / birth defect In a child of a patient who used the product. Required intervention to prevent permanent impairment or damage Medical or surgical intervention was needed to prevent one of the above outcomes. Significant disfigurement (MoCRA-specific) Serious or persistent rash, 2nd/3rd-degree burn, significant hair loss, or persistent / significant alteration of appearance, other than as intended. If checked, briefly describe in the narrative below which criterion applies.

B.3 Date of Event

B.4 Date of this Report

B.5 Describe Event or Problem Recommended structure: who used the product (anonymized) - what the product is and how it was used - what happened, when - what was done about it - current status. For MoCRA, capture enough detail that an FDA reviewer can assess seriousness without calling back.

C. Suspect Cosmetic Product

Fill in the product believed responsible for the event. If multiple cosmetic products were used in the same routine, list the primary one here; secondary products can go in the narrative or in the concomitant section.

C.1 Product Name

Strength / Concentration

Manufacturer / Compounder

Lot # / Batch #

Expiration Date

UPC / Unique Product ID

C.5 Product Type (MoCRA - pick one)

Cosmetics sold on retail basis Cosmetics for professional use only

"Professional use only" means sold to and used by licensed cosmetologists, estheticians, etc. - not direct-to-consumer.

C.4 Reason for Use / Use Indication

Application Route

C.3 Treatment/Usage Dates

Usage Started

Usage Stopped

Frequency / Amount

C.7 Event Abated after stopping use?

Yes No Doesn't apply

C.8 Event Reappeared after restarting?

Yes No Doesn't apply

E. Initial Reporter

The person who first reported this event to the responsible person - could be the consumer, a healthcare professional, a retailer, or a salon. Recommended: fill in at least one identifier (any of First Name, Last Name, Email, Phone, or Occupation) so FDA can identify the report source. If the original reporter is anonymous or unknown, you may leave these blank.

First Name

Last Name

Phone

Address (optional)

City / State / ZIP

Health Professional?

Yes No

Occupation (if HCP)

G. Responsible Person (Required by MoCRA)

Under MoCRA, the "responsible person" is the manufacturer, packer, or distributor whose name appears on the product label. This is the entity legally required to submit the SAE report. Fields below populate Section G of the FDA 3500A.

Responsible Person / Company Name

Phone Number

Email Address

Business Address

Optional MoCRA Statement

Include statement: "This report does not constitute an admission that the product caused or contributed to the event."

MoCRA explicitly permits responsible persons to include this denial statement in their report.

Product Label (Required)

MoCRA requires that a copy of the product label (on or within the retail packaging) be submitted with the SAE report. Upload one or more images: front of package, back, ingredient list. PNG, JPG, or PDF. These will be bundled with the generated 3500A PDF into a single ZIP for you to email to FDA.

Drop image or PDF files here, or

Choose files

Adverse Event Photos (Optional)

Photos of the adverse event itself — for example a rash, burn, hair loss area, or skin discoloration — can substantially help FDA assess the case. These will be bundled in the ZIP alongside the 3500A PDF; they are not embedded into the PDF itself.

Privacy note. Avoid uploading photos that show the patient's face or other identifying features unless the patient has consented. If the patient asked to remain de-identified, prefer cropped or close-up images that show only the affected area.

Drop image files here, or

Choose files