Med Vigilance Reports by Patients

  • About Problem
  • About Device
  • About Product
  • About Patient
  • About Reporter
  • Review and Submit

About Problem

* Required Information

What kind of problem was it?

(Check all that apply)

Did any of the following happen?

(Check all that apply)

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

Tell us what happened and how it happened: *

(Include as many details as possible)

Total of 4000 characters allowed. You have 4000 left.

List any relevant tests or laboratory data if you know them:

(Include dates)

Total of 2000 characters allowed. You have 2000 left.

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


  • prescription or over-the-counter medicine
  • biologics, such as human cells and tissues used for transplantation (for example: tendons, ligaments, and bone) and gene therapies
  • nutrition products, such as vitamins and minerals, alternative medicines, infant formulas, other health and OTC products.
  • Medical Cosmetics

  • 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 DRAP. We will contact you directly if we need it.)

  Yes     No

About Device

* Required Information

Device Information:



Other Identifying Information:








Was someone operating the medical device when the problem occured?

  Yes     No

If yes , who was using it?

  The person who had the problem     A health professional (such as doctor, nurse , aid )    Someone else (please explain who)

For implement medical devices Only (such as pacemakers, breast implants , etc)

About Product

* Required Information

Name of the product as it appears on the box, bottle, or package *

(Include as many names as you see)

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

Is the Product Compounded?

  Yes     No

Is the Product Over-the-Counter?

  Yes     No

Other Identifying Information:



Dates of Use:

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

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
+ Add Another Product

About Product 2

* Required Information

- Delete Product 2

Name of the product as it appears on the box, bottle, or package *

(Include as many names as you see)

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

Is the Product Compounded?

  Yes     No

Is the Product Over-the-Counter?

  Yes     No

Other Identifying Information:



Dates of Use:

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

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

Person's Initials:

Sex:

  Female     Male

Age or Date of Birth:

OR

Ethnicity:

(Choose only one)

  Hispanic/Latino     Not Hispanic/Latino

Race:

(Check all that apply)

List known medical conditions:

(Such as diabetes, high blood pressure, cancer, heart disease, or others)

Total of 2000 characters allowed. You have 2000 left.

Please list all allergies:

(such as to drugs, foods, pollen, or others)

Total of 2000 characters allowed. You have 2000 left.

List any other important information about the person:

(such as smoking, pregnancy, alcohol use, etc.)

Total of 2000 characters allowed. You have 2000 left.

List all current prescription medications and medical devices being used:

Total of 2000 characters allowed. You have 2000 left.

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

Total of 2000 characters allowed. You have 2000 left.

About Reporter

* Required Information

Reporter Name:

Preferred Address:

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

  Yes     No
 

Review & Submit

 
About Problem
What kind of problem was it?
Did any of the following happen?
Date the problem occurred:
Tell us what happened and how it happened:
List any relevant tests or laboratory data if you know them: List any relevant tests or laboratory data if you know them:
Do you still have the product in case we need to evaluate it?
 

About Product
Name of the product as it appears on the box, bottle, or package:
Name of the company that makes (or compounds) the product:
Is the Product Compounded?
Is the Product Over-the-Counter?
Expiration date:
Batch number:
NDC number:
Strength:
Unit:
Quantity:
Frequency:
How was it taken or used?
Date the person first started taking or using the product:
Date the person stopped taking or using the product:
Duration:
Why was the person using the product?
Did the problem stop after the person reduced the dose or stopped taking or using the product?
Did the problem return if the person started taking or using the product again?
Name of the product as it appears on the box, bottle, or package:
Name of the company that makes (or compounds) the product:
Is the Product Compounded?
Is the Product Over-the-Counter?
Expiration date:
Batch number:
NDC number:
Strength:
Unit:
Quantity:
Frequency:
How was it taken or used?
Date the person first started taking or using the product:
Date the person stopped taking or using the product:
Duration:
Why was the person using the product?
Did the problem stop after the person reduced the dose or stopped taking or using the product?
Did the problem return if the person started taking or using the product again?
 
About Device
Name of medical device:
Name of the company that makes the medical device:
Model number:
Catalog number:
Lot number:
Serial number:
UDI number:
DRAP registration no:
Was someone operating the medical device when the problem occurred?
If yes, who was using it?
Date the implant was put in:
Date the implant was taken out:
 
About Patient
Person's Initials:
Sex:
Age:
Date of Birth:
Weight:
Ethnicity:
Race:
List known medical conditions:
Please list all allergies:
List any other important information about the person:
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
Name:
Preferred Address:
Telephone number:
Email address:
Did you report this problem to the company that makes the product (the manufacturer/compounder)? Yes