FDA Asks Consumers to Report Product Failures

//FDA Asks Consumers to Report Product Failures

FDA Asks Consumers to Report Product Failures

FDA medwatch form 200June 10, 2013 ~ New and Improved?

The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, medical equipment, food or supplements. Whether the product didn’t work as promised on the label, caused sickness or injury or malfunctioned or had defective components, the FDA wants to hear from you.

Post approval monitoring is the only way that the FDA can determine a pattern of failure of any particular product it oversees. The agency is working on a unique identifier (like a bar code) to better track devices, but until that  regulation is put into place, reporting is voluntary by healthcare professionals and consumers. Without accurate reporting, there is no way to know how a device or drug is functioning under real world situations.

This new form was developed with the help of AARP, Consumers Union and the National Women’s Health NetworkHere is the form.

Here is a lesson how to submit a report to MedWatch.

Consumers are encouraged to report adverse outcomes that are not listed on the product label;  report therapeutic failures where it failed to work as it should; report user errors due to poor communication or ambiguities on the label; report problems with a product quality, a malfunction, poor packaging or defective components.

Even if you are not sure the problem is due to the product, you are encouraged to report to MedWatch (1-800-FDA-1088).

MAUDE tv show, not the FDA

MAUDE tv show, not the FDA

Meanwhile what is happening to MAUDE? In May, the FDA updated information on the MAUDE database (here). MAUDE stands for Manufacturer and User Facility Device Experience (MAUDE).

Manufacturers and health care providers and facilities are required to report adverse events (complications) to the MAUDE database, though the penalty for not doing so is less than clear.

Generally what happens is a doctor or an attorney will report to the MAUDE database. The manufacturer will generally add a Conclusion such as:

“Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.”

Generally that is the end of it. Critics of the FDA have called it a “black hole” when it comes to any adverse event reporting.

Regardless, here are instructions on how to post an adverse event report to the MAUDE database with the FDA.


Consumers Union on How to Improve the Safety of Medical Devices


MDND, Sept 2012, How to Follow Medical Devices: UDI Proposal



By | 2013-06-10T16:07:02+00:00 June 10th, 2013|FDA News|4 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. Joleen Chambers June 10, 2013 at 8:26 pm - Reply

    Please report these adverse events with surgical mesh to FDA MedWatch. The FDA follow-up investigations are not currently apparent, but it does create a valuable permanent record of the product failure. I am going to DC this week and will speak for 3 minutes at the 6/13/13 FDA 510(k) public meeting. Although my advocacy began because of implanted orthopedic joint replacements, it is clear that we all have the same issues with implanted medical devices. We were not given true informed consent and the FDA “blessing” does not mean a device is safe or effective. Let’s prevent other innocents from falling into this contrived trap set by profiteers!

    • Jane Akre June 11, 2013 at 11:00 am - Reply

      Thank you Joleen- She is a champion trying to bring awareness of failed medical devices thru FIDA, Failed Implant Device Alliance (see Friends of MDND for a link) .

      Here is the official answer from the FDA. I asked them if MedWatch was redundant to the MAUDE database in that they both take consumer and doctor complaints about failed products. Here is the answer from Sandy Walsh of the FDA’s media office:

      “MedWatch is a reporting process for all adverse event reports to FDA from the public — health professionals and their organizations, consumers/patients. The process is voluntary and is direct, from these reporters directly to FDA MedWatch online, mail, fax, or phone. MedWatch is not an FDA database of reports. All MedWatch AE reports for devices (i.e. adverse events/harms, product use errors/near misses, product quality problems) are triaged by a Central Triage Unit (CTU) and those that are voluntary reports about products regulated by CDRH are sent to that Center, logged into the device product database, MAUDE, and are then available for evaluation by the Center’s postmarket surveillance teams.‬

      ‪ ‬

      ‪MAUDE is the acronym for the current CDRH database/repository for all product AEs associated with those devices regulated by and monitored during postmarket surveillance. See:

      http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. MAUDE reports include reports submitted directly to FDA (i.e. MedWatch reports) and those submitted indirectly to FDA (i.e. initiated by those same reporters but sent first to the product’s manufacturer or its representative and then submitted to FDA as mandatory reports required by law/rule/regulation from those regulated reporters.‬

      ‪ ‬

      ‪As to the question posed:‬‪ ‬

      The two terms in question, MedWatch and MAUDE are distinct terms, the first a program and the second a device product database. They are related and associated only as distinct parts of the postmarket safety surveillance process. Promoting and facilitating the submission of high quality voluntary reports by consumers and health professionals of suspected signals of serious device AEs is the function of MedWatch and these reports are entered into CDRH’s database, MAUDE, for review and evaluation.‬

      ‪ ‬

      ‪The recent, June 3 FDA announcement about the 20th anniversary of MedWatch and the ongoing campaign — to promote 1) the new consumer-friendly reporting form and 2) the teaching tool, MedWatchLearn, for consumers and health professionals about ‘why and how’ of voluntary reporting — emphasizes the primary role that MedWatch plays in increasing and improving voluntary AE reporting from those audiences, for medical devices (CDRH) but also for drugs (CDER and CBER) and for human medical products regulated by CFSAN (dietary supplements, infant formula, cosmetics and now foods/beverages).‬”

      • Jane Akre June 11, 2013 at 11:02 am - Reply

        Reading between the lines of this official FDA statement, I believe she is saying it is more consumer friendly since MAUDE definitely was not as anyone knows who tried to navigate it! So in the future, try the MedWatch to file your complications- it is important to do so in that it is the only way to flag problems,,,, though that flag is certainly waving by now!?

  2. Richard Howden February 9, 2014 at 3:24 pm - Reply

    The FDA’s MAUDE data base and reporting system would work if the FDA required Hospitals and Doctors to not only report fully about a Mesh failure but require them to send the removed mesh also. Until then”non conclusive” is all we mesh sufferers will be to the FDA. Most of us that have been implanted with mesh have had our lives and health ruined by this product. And most of us will die, impoverished and in pain with no help from our Government or from the Manufacturers. So the FDA coming up with a more friendly form to fill out may make them feel better but leaves those of us that have had to deal with mesh for years, forgotten. As far as I am concerned until the FDA makes it the law for all mesh removals to be fully reported and the “product” analyzed nothing else will matter.

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