FDA: Lapdog Enforcement on Reporting Adverse Events

Jane Akre
March 7, 2017

Lapdog, Portrait of Woman in Red, Agnolo Bronzino, 1532, Tuscan School, WikiCommons

Mesh Medical Device News Desk, March 7, 2017 ~ In mild mannered newly-issued language, The U.S. Food and Drug Administration (FDA) recommends that medical device manufacturers report adverse events to the agency, but it's not legally enforceable.

This new regulation issued November 2016, updates 20-year-old regulations for medical device reporting (MDR).

Guidance for Industry and Food and Drug Administration Staff (here)

Medical Device Reporting (MDR), is not a legally enforceable responsibility, says the guidance on page 1.

“Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”

While industry, in an apparent conflict of interest, is charged with monitoring itself, the FDA says “The use of the word 'should' in guidance documents means that something is suggested or recommended, but not required.”

“This guidance represents the current thinking of the Food and Drug Administration on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfied the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.”

MDR Policy Branch 301-796-6670. MDRPolicy@fda.hhs.gov. An automated voice answers, "Sorry, is not available. record your message at the tone."

The goal is to detect and correct problems in a timely manner and is directed at manufacturers, hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, outpatient treatment facilities, importers of medical devices and medical device distributors.

Enforcement can include seizure, injunction, civil money penalties and criminal prosecution.

What’s reportable? Events that "manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” See page 2.

Under statute 803.12, Manufacturers must conduct an investigation into an event, even if it involves death or serious injury and then are required to submit reports to the FDA of a reportable death, serious injury or device malfunction.

They must be submitted within 30-calendar days after the day the manufacturer becomes aware of the event, and are referred to as “30-day reports.” There are also 5-day reports if something requires remedial action to “prevent an unreasonable risk of substantial harm to the public or health.”

Here are those cited regulations.

Manufacturers may take note of the exemption to reporting a MDR on page 13.

"You are not required to submit an MDR report if you have information made by a person who is qualified to reasonably conclude that your device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur."

In other words, self-monitoring.

If the user intervenes before the malfunctioning device can cause harm, it should still be reported.

Back in 1997, the assumption was if a medical device malfunctioned and caused death or serious injury, a presumption of malfunction is established. So leave the device on the market for another two years and see how it performs, recommends the FDA:

"This presumption will continue until either the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show through valid data that the likelihood of another death or serious injury as a result of the malfunction is remote." Page 13.

At that time, the manufacturer may want to submit information it has to assure the FDA the malfunction will not occur again.


So how do you report your own adverse event? Here is a story from August 2014.

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.

Or you can report to MAUDE.

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 one mesh patient, (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.

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