How to Post an Adverse Event with the FDA

//How to Post an Adverse Event with the FDA

How to Post an Adverse Event with the FDA

Pacemaker, Courtesy WikiCommons, Steven Fruitsmaak

MND, August 30, 2015 ~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 his surgical skills.

But you should still report your adverse event.  How many patients understand how to report an “adverse event” to the Food and Drug Administration? (Disclosure- this story first was published on this day August 30, 2011, on Mesh News Desk).

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 – as little as one percent.

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 or by phone at 301-796-6640.

Enroll to receive Public Health Notifications here.


By |2015-08-30T00:00:00+00:00August 30th, 2015|FDA News|23 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. Lawerence Dymek September 5, 2011 at 10:45 pm - Reply

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

    • Jane Akre September 11, 2011 at 4:51 am - Reply

      Thank you for commenting. Send us around so others can learn. Stay well- J. Akre

  2. Elizabeth September 20, 2011 at 3:56 pm - Reply

    Much appreciated for the information and share!

    • Jane Akre September 22, 2011 at 3:46 am - Reply

      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. Neeni May 31, 2012 at 9:29 am - Reply

    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 May 31, 2012 at 8:04 pm - Reply

      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.

  4. cathy munsey July 24, 2012 at 8:13 am - Reply

    i have already done that. yes!!!!

  5. DebC December 9, 2012 at 4:49 pm - Reply

    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” (, 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.

  6. Bejah B August 30, 2015 at 3:41 pm - Reply

    Good Day People, I have a couple of thoughts/questions about the matter of reporting to the FDA:

    (1) I no longer have ANY respect for the FDA. I want to report BUT know that it is like pouring money into a tarpit. They are not going to do anything. They have made that abundantly clear. Let us remember that the FDA has “Refused” to issue further warnings regarding mesh, or classify it as a category III device (Extremely dangerous). They have left the manufacturer’s to police themselves. That is not stupid, it is criminal.

    (2) Can we assume that our surgeons have reported to the FDA’s MAUDE database? What a silly question, of course we can not assume that. We can not assume anything.

    (3) Failing reporting by the surgeon/medical center/UFO can we assume the law firms representing us have checked to see if an adverse event was reported and if it was not, can we assume the law firm would then report to the MAUDE database? Probably not.

    I guess we all need to check ourselves to see if it was done. If it was not, please tell me there is not some sort of cap on the reporting time allowed.

    I seem to be in a bad mood. Maybe it is the full moon. I have come to believe that praying is more worthwhile than reporting adverse events. It reminds me of a store that has a complaint form one can fill out. The real purpose of the complaint form is often to diffuse the complainer’s discontent NOT address any real concerns. It is a tar pit, a “round file”, an exercise in futility methinks.

    Tell me really, show me what the value is in doing this. What has the FDA done in response to this reporting aside from keeping a finger on the pulse of the implanted and those involved so they can then report back to their pals at JnJ and others.

    I think we need to do background checks on all the individuals on the panels related to the medical devices section of the FDA. It does not cost much these days. I have already uncovered some very intereting information. Not ready for primetime yet. Sometimes the wounded bite back Alex!


    PS “Fun fact” Did ya know that it is considered (common knowledge) rude to refer to one’s adversary by their first name only? It is often done to irritate and destabilize one’s opponent. I propose we engage in this practice with regard to our opponents with great gusto and frequency. Wishing all of us a good week.

    • Nanny Bug August 31, 2015 at 7:27 pm - Reply

      I so confused by all of this !! After treating me for two years my Dr. act like I was a stranger Friday . He accused me of begging doctors to do surgery on me , said I’d never composing of incontinance too. I should have taken that foot long pad I wore &?wiped his nose with it . I felt lije he had never saw me before. He even told me several months a ho I had perineal nerve damage now he denied telling me that. Man I thought I gone off the deep end until he kept trying to convince me of thing that he hadn’t said . I thought oh well I guess he’s been bought our . My heart was broke but I never thought he was capable of doing that. He told me there was no way he would ever believe such a tiny piece of mesh to do all that damage to women . I finally got fed up with his lying & chewed his butt out about instead of walking out like a wounded puppy . He crossed the line as a professional . I left crying because I was so violated by him but I bet you he writes the next wonans inf . down right . Have you heard of anyone changing their notes or lying about things they say they didn’t say? I begged him to tell me who I begged . Tell me one surgery I begged for!!! Then in the hall as he was dragging me to his in front of others he denied that !! I hope he has a conscience & God deals with him justly . He sure hadn’t had a problem with sucking my insurance every visit & treating me for nothing go two years . When he told me I needed to buy a vibrator to use for measure for me and my husband I near died . I know most women probably have one . I’m from the Deep South & went to church all my life 57 years old at the time . It embarrassed me to death & I felt lije he was insulting me ! Anyone ever been told that. I just get so humiliated by so much of this kind of talk !! It is making me feel like my morals are being tested !! The vaginal nerve trouble & incontinance is whyvI came to him the first time . I don’t think I can ever go to a doctor again !! Im so ashamed & hurt at him . Please tell he if I’m the one that wrong if I am I need to change !! Honesty please I’m really serious !!!

      • Jane Akre September 1, 2015 at 10:39 am - Reply

        I cant imagine a doctor talking to a patient that way….

      • Bejah B September 6, 2015 at 5:20 pm - Reply

        I know it is not much comfort but I think many of us have had similar things happen, maybe not quite as terrible. He had no right to speak to you that way, needless to say. It is also a blatant violation of his oath. You need to report this individual to the state medical board ASAP. I hope you gave him a piece of your mind and resisted letting the hurtful impact get in the way of lashing out at this monster. He may be trying to scare you, He may be trying to get rid of you. You do need to dump him and I hope you already have. You need to be strong and often the times when we need to be strong the most are the times it is hardest to do so.


  7. anna August 31, 2015 at 10:42 am - Reply

    How come our lawyer are not advising us to do this? My implants were done in 2006, and 2011, does this mean is too late.

  8. anna August 31, 2015 at 6:06 pm - Reply

    I can’t understand why are our lawyers not advising us to do this. I had my implants on 2006, and 2011 is it too late?

    • Jane Akre August 31, 2015 at 6:19 pm - Reply

      No it is not too late…. if you spend any time searching the MAUDE database, you will see many law firms posted the AE for their client. Ask them if they advise their clients on how to do this? Send them the article…. (shall I bill them?) LOL

  9. anna August 31, 2015 at 6:55 pm - Reply

    How would I know if they did it?

    • Jane Akre September 1, 2015 at 10:40 am - Reply

      Ask your law firm if they filed an adverse event complaint to the FDA. They will know if they did. Most don’t. You should insist they do. They can call here if they need further directions.

      • Bejah B September 6, 2015 at 5:26 pm - Reply

        (Sigh) Yes but will asking our attorneys irritate them? I know, that is their problem, still many of us would be troubled by that response. I guess we need to forge ahead anyway. I will be inclined to think that if they have not done that in the absense of the doctor filing, they probably do not really care much about me. That is the grim reality. People are so nice to you if they think you have money, if they think you can bring them prestige or introduce them to other people who can bring them prestige or if they think you have money coming to you. If you do not have any of that you often become persona non grata in our world, in our country. A wild guess: The less your case is worth in the eyes of your lawyer the less happy he will be to see you or talk to you. But cheer up, at least we have eachother. 🙂


  10. Nanny Bug August 31, 2015 at 8:36 pm - Reply

    Sorry I mispelled so many words y’all . I was venting & I’m sorry got that . He didn’t request the vibrator for measure it was sexual pleasure . If I can’t have intercourse with my husband in sure not gonna use a vibrator . When & if I can attempt it it will be with him as well !

    • Bejah B September 6, 2015 at 5:30 pm - Reply

      I no longer have any interest in any of that….it makes me hurt just to think of it. That part of my life is over. I am not sure what is left of me. So at least we know you are still alive NB…that is a good thing I heard tell. I may go live in a convent.


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