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This report relates to a previously submitted report.

Manufacturer Name:? (Required)	Choose... Other
	(include manufacturer's name, address and phone, if known)

Name:
Address:
Country:
Phone:
Email:
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	Best time and way to reach me (phone number, time of day, etc)
Relationship to Patient: (Required)	Choose One... Self Spouse Parent Child Sibling Physician Dentist Nurse Pharmacist Nurse Practitioner Physician Assistant Other If Other:
Patient Identifier: ?

Name:
Address:
Phone:
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Age at Time of Event	(whole numbers only)
Sex	Choose One... Female Male
Is patient pregnant?	Choose One... Yes No
Weight at Time of Event	lbs kgs

Date of Event	(mm/dd/yyyy)
Describe the Event, Problem, or Defect
Describe Relevant Test/Laboratory Data, Including Dates or leave as blank, which means "None"
Provide All Relevant Medical and Health History Including Preexisting Medical Conditions and All Current and Recent Prescription and OTC Use (e.g., allergies, race, pregnancy, smoking and alcohol use, liver/kidney problems, etc.) or leave as blank, which means "None"

Product Available for Evaluation?	Choose One... Yes No
Location of Product?	Choose One... I still have product Returned to Retailer Returned to Manufacturer Other If Other, Explain:
If Returned, What was the date?	(mm/dd/yyyy)
List Name, Address, and Contact Person (if any) of the Retailer or Manufacturer to which you sent the product
How was the Product Returned?	Choose One... Hand Delivered Sent US Postal Service Sent FedEx / UPS Other

Product Name ?
Brand Name
UPC code from label
What Amount Was Taken? (dose)
How Often Was It Taken? (frequency)
How Was It Taken? (route used)
Lot # (small printed number of 4-8 digits, typically on bottom of label or bottle)
Expiration or Use By Date
Event Abated After Use Stopped or Dose Reduced?	Choose One... Yes No Does Not Apply If no, explain:
Event reappeared after reintroduction?	Choose One... Yes No Does Not Apply
If Drug, enter NDC # (if available)

Product Name ?
Brand Name
UPC code from label
What Amount Was Taken? (dose)
How Often Was It Taken? (frequency)
How Was It Taken? (route used)
Lot # (small printed number of 4-8 digits, typically on bottom of label or bottle)
Expiration or Use By Date
Event Abated After Use Stopped or Dose Reduced?	Choose One... Yes No Does Not Apply If no, explain:
Event reappeared after reintroduction?	Choose One... Yes No Does Not Apply
If Drug, enter NDC # (if available)

Describe other drugs, foods, supplements taken recently, as well as recent medical care (excluding treatment for this event) If you have taken other drugs or dietary supplements that could potentially be associated with the symptoms reported, please remember to contact the manufacturer(s) of those products and report the adverse event. This will help ensure accurate information is reported to those manufacturers.

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