Adverse Event Report

The FDA considers hand sanitizer an over-the-counter drug. As such, we are required to collect and report any adverse effects encountered by our customers to the FDA by providing them with the information we collect in the form below. The FDA considers an Adverse Event to be any undesirable event that is associated with the use of a drug or biological product in humans whether or not considered product-related by the applicant. For example: rash, burn, skin peeling, skin cracking, redness, etc.

Name
First Last
Email
Phone
Company/Organization
Patient Information
Patient identifier
Note: Do NOT use any personally identifiable information. Use their initials instead of the name. DO NOT use any sensitive data such as SSN.
Age/DOB
Gender
Weight
Ethnicity or race
The Product Used
Product Batch Number (front of label)
The Specific Adverse Event
Outcome attributed to adverse event, e.g. What happened? What is the complaint?
Description of event
Date of event
MM slash DD slash YYYY
Date of report of Adverse Event
MM slash DD slash YYYY
Any other relevant history including pre existing medical conditions

Join Our Mailing List

Get the latest updates from New Deal Distillery, including special offers, information about new product releases, seasonal cocktail recipes, sponsored on-line events, and more!

Adverse Event Report

Patient Information

The Product Used

The Specific Adverse Event

Join Our Mailing List

VISIT US

SHOP SPIRITS

ABOUT NEW DEAL

EXPLORE