How to Post an Adverse Event with the FDA

Aug 30th, 2011 | By | Category: FDA

Pacemaker, Courtesy WikiCommons, Steven Fruitsmaak

When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days.

But when a patient has a problem with a medical device, don’t depend on mandatory reporting. Or any reporting at all. Your doctor may report the problem, but then again he or she may not. A problem may reflect badly on their skills, and how many patients understand how to report an “adverse event” to the Food and Drug Administration?

An adverse event can be any complication from a drug or medical device and it is the only way the federal agency can track problems.

The FDA reported in July that from Jan. 01, 2008 through Dec. 31, 2010, it received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.

Because of the lapse in reporting, problems that are reported are suspected of reflecting just a fraction of what occurs in the real world.

How to Report an Adverse Event

You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online:

  • By phone- 1-800-FDA-1088
  • By FAX – obtain a fillable form online and print it out and fax it to 1-800-FDA-0178
  • By mail – or mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

MedWatch Online Voluntary Reporting Form (3500) is here.

Look up Adverse Events:

Manufacturer and User Facility Device Experience (MAUDE) data

As it stands now, the injured have to find the FDA’s MAUDE database (Manufacturer and User Facility Device Experience Database) and understand the criteria to enter to pull up injuries resulting from your mesh. It can be intimidating, and if they are involved in litigation are generally advised not to enter information.

For example, in the case of mesh patient, Suzanne McClain (Suffering in Silence- Part 1) finding data on Ethicon’s Gynecare Tension Free family of mesh products involves knowing the criteria:

1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)
2.) Brand Name: Tension Free
3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.
4.) Records Per Report Page: Change to 500 and click Search.

 A National Registry

The purpose ultimately of  the patient advocacy group, Truth in Medicine, is to stop the marketing and implantation of synthetic surgical mesh.  Information collected on an international user-friendly registry would be passed onto Congress to accomplish that goal.

Surgeons who remove surgical mesh (Suffering in Silence– Part 3) also support a registry to get some idea of the big picture of complications of synthetic surgical mesh.

Getting More Information

At the FDA’s Office of Surveillance and Biometrics by e-mail at phann@fda.hhs.gov or by phone at 301-796-6640.

Enroll to receive Public Health Notifications here.

 

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10 Comments to “How to Post an Adverse Event with the FDA”

  1. he weblog was how do i say it… relevant, finally something that helped me. Many thanks

  2. Elizabeth says:

    Much appreciated for the information and share!

    • Jane Akre says:

      I’m glad we could be of some help. It is vitally important for people to learn how to navigate the MAUDE database. As it stands now, the FDA is relying on it to ascertain the number of patient injuries which on the face of it is a bit absurd since no one knows it’s there! AND even if they do find it, learning how to use it is almost impossible. Also most people do not have the make model of their device I find as I talk to many people. Rather, it was just sort of mentioned as an aside they’d get some device to fix them. It’s easier to track cars through a VIN# than an implantable medical device.

  3. [...] See earlier story on how to report to the FDA’s MAUDE database (here). [...]

  4. Neeni says:

    I have asked my surgeon to make a report about the medical device that implanted in my spine and fractured, but he never did. Is this article saying that I the patient can do it?

    • Jane Akre says:

      Absolutely- You do not need to rely on your doctor to provide the report. The FDA will take an adverse event report from the patient. You might want to gather all of the information you can (see above No. 1-4) so you can provide accurate information. Ask for confirmation that your report has been filed to be mailed or e-mailed to you.

  5. cathy munsey says:

    i have already done that. yes!!!!

  6. DebC says:

    Thank you for this post. I did report to the FDA – andbelieve it is VERY important to do, even thoguh FDA doesn’t seem to be doing anything just yet. Still, the more registered complaints, the better. But, I also want to let folks know that “They” sure don’t make it easy to report a problem online either… at least, it wasn’t for me, even though I consider myself pretty computer savy.

    First, getting the mesh sling ID # necessary for reporting was NOT easy… wasn’t even in my records when I first requested them. I had to go back and specifically request the model/id info, and after much to-do and dumbfounded looks, I finally got it.

    Then, it took me several tries to report on the FDA website. I kept getting errors. Eventually I figured out that their online form would not work with Firefox… So, I try Windows Explorer, and still got an error. Of course the errors happen at the VERY end when trying to submit, and so you waste your time and lose your data. (Note: write your entry in WORD first, save, and then CUT & PASTE to their form). So, I try again and realize it said i had to use an OLDER version of Windows Internet Explorer than currently available and installed on my computer (and most others, I would assume as usually folks DO upgrade to current software). ?? Really? An “older” version?? So, I actually had to download an OLDER version of Internet Explorer, install it, and THEN it finally worked. ?!?

    What a joke. Most any other company can make sure their online forms are compatible across the board with the major web browsers, etc., but the FDA can not? Come on…. And how many people would take the time, or even be able to figure that out? I sure hope their telephone number works better than their online form!

    By the way, I did find that they have a page of “FAQ” (https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm), where it does state:

    =====
    What browser and technical requirements are needed to use this online form?

    In order to use the MedWatch 3500 Online form and properly view the pdf files when printing/saving the document, you will need either:

    Netscape Navigator 7.x or higher
    Microsoft Internet Explorer 5.x or higher
    Mozilla Firefox 1.5 or higher (this has not been extensively tested with this application)\

    ============

    But, as I mentioned, it actually told me the version of IE I had was too new! and I HAD to download an older version. ??

    Maybe they have fixed this since then…. or maybe it was just me?? I’d be curious to hear how others who reported made out.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.