MedWatch Voluntary Report

About Problem * Required Information For all other data fields please provide information, if available. ONLY fields with * are mandatory.

What kind of problem was it? (Check all that apply)

Were hurt or had a bad side effect (including new or worsening symptoms) Used a product incorrectly which could have or led to a problem Noticed a problem with the quality of the product Had problems after switching from one product maker to another maker

Did any of the following happen? (Check all that apply)

Hospitalization - admitted or stayed longer Required help to prevent permanent harm Disability or health problem Birth defect Life-threatening Death (Date of Death) (mm/dd/yyyy) Other serious/important medical incident

Date the problem occurred (mm/dd/yyyy):

Tell us what happened and how it happened Required Field* (Include as many details as possible. NoPEG Project may reach out to you for any additional documents if necessary)Total of 4000 characters allowed.

Relevant Tests/Laboratory Data:

Test Date (mm/dd/yyyy):

Test Name:

Test Result:

Test Unit:

Additional Comments:

Please select the cause of the problem that applies below: Required Field*

ProductProblemList

prescription or over-the-counter medicine

biologics, such as blood transfusions, gene therapies, and human cells and tissues transplant (for example: tendons, bone and corneas)

nutrition products, such as vitamins and minerals, herbal remedies, infant formulas, and medical foods

cosmetics or make-up products

foods (including beverages and ingredients added to foods)

Please select the cause of the problem that applies below: Required Field*

For a problem with a medical device, including:

any health-related test, tool, or piece of equipment
health-related kits, such as glucose monitoring kits or blood pressure cuffs
implants, such as breast implants, pacemakers, or catheters
other consumer health products, such as contact lenses, hearing aids, and breast pumps

Do you still have the product in case we need to evaluate it? (Do not send the product to NoPEG Project . We will contact you directly if we need it.)

Yes No

Do you have a picture of the product? (check yes if you are including a picture)

Yes

About Device

* Required Information

For all other data fields please provide information, if available. ONLY fields with * are mandatory.

Device Information:

Name of medical device

Name of the company that makes the medical device

Other Identifying Information:

Model number

Catalog number

Lot number

Serial number

Unique Device Identifier (UDI) #

Expiration Date (mm/dd/yyyy) Expiration Date Help (If you only know the month and year, default to the last day of the month.)

Was someone operating the medical device when the problem occurred?

Yes No

If yes, who was operating it?

The person who had the problem A health professional (such as a doctor, nurse, or aide) Someone else (Please explain who)

For implanted medical devices ONLY (such as pacemakers, breast implants, etc.)

Date the implant was put in (mm/dd/yyyy)

Date the implant was taken out (if relevant) (mm/dd/yyyy)

About Product

* Required Information

For all other data fields please provide information, if available. ONLY fields with * are mandatory.

INSTRUCTIONS:

Enter information for a single product below. If there is a second product related to this medical event, please click the “+ Add Another Product” link found near the bottom of this page.

Product 1

Product Information:

This report is about:

Check if therapy is on-going

Name(s) of the product as it appears on the box, bottle, or package Required Field* Product Name Help (Include as many names as you see)

Name(s) of the company that makes (or compounds) the product

Product Type:
(Check all that apply)

OTC (Over-the-counter) Compounded by a Pharmacy or an Outsourcing Facility Generic Biosimilar

Other Identifying Information:

Expiration Date (mm/dd/yyyy) (If you only know the month and year, default to the last day of the month.)

Lot number

NDC number

Strength

Unit

Quantity Quantity Help (for example, 1 for one capsule)

Unit

Frequency (for example, twice daily or at bedtime)

How was it taken or used (for example, by mouth, injection, or on the skin)?

Dates of Use:
(If unknown, give duration) from/to (or best estimate in the format mm/dd/yyyy)

Date the person first started taking or using the product

Date the person stopped taking or using the product

Date the person reduced dose of product

Give best estimate of duration

Unit

Why was the person using the product? (such as what condition was it supposed to treat)

Did the problem stop after the person reduced the dose or stopped taking or using the product?

Yes No

Did the problem return if the person started taking or using the product again?

Yes No Didn't restart

About Patient

* Required Information

For all other data fields please provide information, if available. ONLY fields with * are mandatory.

Person's Initials:

Sex:

Male Female Undifferentiated Decline to answer

Gender:

Cisgender man/boy (gender corresponds with birth sex) Cisgender woman/girl (gender corresponds with birth sex) Transgender man/trans man/female-to-male (FTM) Transgender woman/trans woman/male-to-female (MTF) Other gender category; please specify: Decline to answer

Age (specify unit of time for age)

Unit

Date of Birth (mm/dd/yyyy)

Weight:

Unit:

Ethnicity:
(Choose only one)

Hispanic/LatinoNot Hispanic/Latino

Race:
(Check all that apply)

American Indian or Alaskan Native Asian Black or African American Native Hawaiian or Other Pacific Islander White

List known medical conditions:
(Such as diabetes, high blood pressure, cancer, heart disease, or others)

Please list all allergies:
(such as to drugs, foods, pollen, or others)

List any other important information about the person:
(such as smoking, pregnancy, alcohol use, etc.)

List all current prescription medications and medical devices being used:

List all over-the-counter medications and any vitamins, minerals, supplements, and herbal remedies being used:

About Reporter

* Required Information

For all other data fields please provide information, if available. ONLY fields with * are mandatory.

Reporter Name:

First Name (Given Name):

Last Name (Family Name):

Preferred Address:

Country: (Select a country first)

Number/Street 1:

Number/Street 2:

City:

State/Province:

Zip or Postal code:

Email address:

Confirm Email:

Did you report this problem to the company that makes the product (the manufacturer/compounder)?

If you do NOT want your identity disclosed to the manufacturer, place an "X" in this box

yes

Please confirm that you're not a robot.

MedWatch Voluntary Report

About Device

About Product

Product 1

About Patient

About Reporter

Reporter Name:

Preferred Address:

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