How to Report Drug or Medical Device Problems or Strange Side Effects

Here's How:

1. Choose from the list of kinds of products the FDA wants you to report problems with. The list is comprised of all the products the FDA regulates. It includes:

   • drugs
   • biologics, (including blood components, blood derivatives, allergenics, human cells, tissues, and cellular and tissue-based products (HCT/Ps),
   • medical devices (including in vitro diagnostics),
   • combination products
   • special nutritional products (dietary supplements, infant formulas, medical foods)
   • cosmetics

   If you had a problem with a vaccine, do not report it through MedWatch. Instead, use VAERS: The Vaccine Adverse Event Reporting System.

2. Identify which type of adverse event you suffered:

   • Serious events such as death, hospitalization, disability, birth defects and others.
     
     
   • Problems with quality, performance or safety for drugs and devices, such as suspected counterfeits, defective components, possible contamination, or labeling problems.
     
     
   • Medication or device product use errors - These are mostly preventable events due to drug names being so similar, misuse of an off label drug or medical device usage errors, mostly where device did not perform as expected.
     
     
   • Problems with a different manufacturer of a similar medicine - like a generic version of a drug.

3. Link to the MedWatch form on the FDA's website.

   The first page of the form asks you for some basics.

   It does not ask for personally identifying information. However, they do ask you for a "patient identifier." This is just an ID you will give yourself. Use a name you can remember, but do not use your real name, and never provide a social security number or any other ID that can be traced to you.

4. On the next page, you'll be asked to identify the problem and outcome as you determined in Steps 1 and 2 above. You'll also have an opportunity write a longer description of the problem.

   HINT: be thorough, but be concise. You may want to organize this in a word processor first so that it explains the problem, but doesn't give so much information as to get confusing.

5. If you have had tests or any form of laboratory proof of the problem that can be reported in the next section. This information is optional. If you aren't sure of the precise information, go ahead and include it, but explain that it may not be entirely accurate.

6. They also ask for any relevant medical history. This information is very important, so share as much as you know.

   Remember - honesty truly is the best policy here. They aren't going to judge you; they are trying to help others. For example, it's possible the problem with a drug was the result of the patient drinking too much alcohol. That might mean that the drug is fine - but should not be used by someone at the same time they drink alcohol. A warning, but not a recall or removal from the market might be the result.

7. In the next section they ask if the product is available for the FDA to evaluate. If you have already thrown it away, or you took all the drug, or you broke the device - you would still have parts of the packaging or the device available - so say yes. If you returned it to the manufacturer, provide a date - even if you have to guess. If you threw it away, just say NO, it's no longer available.

8. The next section asks for specifics about drugs only. (If your problem was with a device, skip to the next page.)

   Question #5 can be confusing: "Event Abated After Use Stopped or Dose Reduced?" They just want to know whether the problem you were having stopped once you stopped taking the drug or using the device.

   Similarly, #8 can also be confusing: "Event Reappeared After Reintroduction?" just asks that if you started using the product again, did you suffer the problems again?

   Question #9 asks for for an NDC or Unique ID. NDC means National Drug Code, an 11-digit number found on drug packaging.

9. If your problem was with a medical device, fill in this page. Most of it is self explanatory, with a few exceptions:

   Question #7 says "If Explanted, Give Date." "Explanted" means an implanted device that was later removed.

Question #8 says, "Is this a Single-use Device that was Reprocessed and Reused on a Patient?" This refers to disposable products which might have been reused, such as a syringe that should have been tossed after its first use.

10. The last section asks you to identify yourself, and is accompanied by a confidentiality statement. Some patients might wonder why they would want to identify themselves since they believe the information is private.

    It is in your best interest to fill out the form and to provide them with the information needed to contact you later. For example, if the product you have reported requires follow up such as a recall, or if you have reported an event that could result in a lawsuit, you will want to show that you took all steps necessary to let the FDA know.

11. Upon completion of the last section that asks for identification, you'll be taken to a form that lets you review your answers to be sure they are correct and as complete as you can make them.

    When you have reviewed your information and are satisfied it is as accurate and thorough as you can make it, hit the "submit and finish" button.

12. If you run into problems with the MedWatch form, or if you have questions about privacy, or what they will do with the information, or whether they will contact you later -- you can get your questions answered through the FDA MedWatch website.

    If you want to be kept updated on FDA recalls or other information about the MedWatch program, you can sign up for the MedWatch e-mail alerts.

What You Need

• The problem product and/or the packaging it came in
• Your computer, linked to the MedWatch form (see instructions)
• Optional: a word processor so you can write and edit the narrative sections