Regulatory Open Forum

Is there a way to respond to a MedWatch report submitted by a patient?

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Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

Original Message------

Is there a way to respond to a MedWatch report submitted by a patient?

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

​I will echo Ginger's cautions.  It's possible they are talking to an attorney, and may have even filed on the advice of an attorney.

If the patient was exposed to the device while under care of a physician, ideally you would like to talk to the physician, as they will often have a better understanding of the medical issues than the patient.

You will also want to try to find out if the patient may have contacted your company (eg, customer service) and no one told you.

Otherwise, your question is interesting to me.  I'm not a fan of MAUDE anyway, but if there is no mechanism by which a manufacturer can update a report submitted by someone else (provider or patient), to add a description of its investigation, without, as Ginger puts it, getting a double count, then even less so.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Mar-2018 07:59
From: Ginger Cantor
Subject: MedWatch Reports

Hi Bobbi

They submitted it to you instead of FDA, or both? Or did FDA contact you and is asking for followup in, for example, 45 days?

Regardless, I would suggest if they submitted it to you, treat it as a complaint and work with them to get more information and submit your version of the Medwatch to FDA with some explanation that the patient contacted you, and whether you know if they reported it or not to FDA. If you contact the patient, ask that. You don't want double counts.

Could be volatile if the patient is so upset to file one which is definitely within their rights, so be sure to follow your customer contact procedures and get guidance from your legal.

This is how I would think about approaching this.

Good luck,

Ginger Cantor, MBA, RAC

Centaur Consulting LLC centaurconsultingllc@gmail.com

(+1) 715-307-1850

Original Message------

Is there a way to respond to a MedWatch report submitted by a patient?

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

I agree with Ginger and Julie. The manufacturer must start investigating the complaint asap and if they determine it is a reportable event, they only have 30 calendar days to file with FDA. Also, if the event occurred outside US and is an MDR event, you must report to FDA.

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Vidyalakshmi Jayaraman
Marlborough MA
United States
------------------------------

Original Message:
Sent: 21-Mar-2018 11:32
From: Julie Omohundro
Subject: MedWatch Reports

​I will echo Ginger's cautions.  It's possible they are talking to an attorney, and may have even filed on the advice of an attorney.

If the patient was exposed to the device while under care of a physician, ideally you would like to talk to the physician, as they will often have a better understanding of the medical issues than the patient.

You will also want to try to find out if the patient may have contacted your company (eg, customer service) and no one told you.

Otherwise, your question is interesting to me.  I'm not a fan of MAUDE anyway, but if there is no mechanism by which a manufacturer can update a report submitted by someone else (provider or patient), to add a description of its investigation, without, as Ginger puts it, getting a double count, then even less so.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Mar-2018 07:59
From: Ginger Cantor
Subject: MedWatch Reports

Hi Bobbi

They submitted it to you instead of FDA, or both? Or did FDA contact you and is asking for followup in, for example, 45 days?

Regardless, I would suggest if they submitted it to you, treat it as a complaint and work with them to get more information and submit your version of the Medwatch to FDA with some explanation that the patient contacted you, and whether you know if they reported it or not to FDA. If you contact the patient, ask that. You don't want double counts.

Could be volatile if the patient is so upset to file one which is definitely within their rights, so be sure to follow your customer contact procedures and get guidance from your legal.

This is how I would think about approaching this.

Good luck,

Ginger Cantor, MBA, RAC

Centaur Consulting LLC centaurconsultingllc@gmail.com

(+1) 715-307-1850

Original Message------

Is there a way to respond to a MedWatch report submitted by a patient?

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

Original Message------

Is there a way to respond to a MedWatch report submitted by a patient?

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

​John, thanks for the additional info.  I see two problems here.  The first is that, just because someone filed an event, doesn't mean it was a reportable event per FDA regulation.  This is more likely to be the case when the report is filed by a patient.  The other is Ginger's "double count."  I think she is referring to the practice of looking at the content, rather than the numbers, so that if you file a second report, your report and the patient's will be counted as two black marks against your product, rather than one.

Also, I was under the impression that FDA sent copies of reports filed by others to the manufacturer.  Is that true? If so, does FDA expect the manufacturer to investigate?  And if it is supposed to investigate, would FDA not expect the manufacture to report its findings?  If not, what's the point..

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Mar-2018 11:34
From: John Beasley
Subject: MedWatch Reports

Hi Bobbi,

Anytime a medical device manufacturer becomes aware of a reportable event, including any voluntary filings made by consumers, they are obligated to file.  If a consumer has filed a voluntary MedWatch report in error, I would recommend filing your report, mirroring as much of the information as possible from the consumer's report, and providing clarifying information in Section H10 of Form 3500A.  Filing never constitutes an admission that the manufacturer or their product caused or contributed to the event.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

Is there a way to respond to a MedWatch report submitted by a patient?

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

I used to agree with this. In fact I worked for companies that had a policy that they filed a "matching" MDR for every MedWatch, regardless of whether they determined it met filing criteria, in order to clarify the initial report. However, having now lived through 3 different situations where FDA decided there was a safety issue based on, basically "there are XX MDRs on this device" and not looking into the details, I've changed my mind. The approach of the FDA seems to be "you filed it, so you deemed it serious." Thus, I now take the approach of making a decision specifically to the regulation, and if it isn't reportable, just documenting in the complaint file. Patients (and even MedSun sites) are notorious for filing things that do not really meet filing criteria.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 21-Mar-2018 11:34
From: John Beasley
Subject: MedWatch Reports

Hi Bobbi,

Anytime a medical device manufacturer becomes aware of a reportable event, including any voluntary filings made by consumers, they are obligated to file.  If a consumer has filed a voluntary MedWatch report in error, I would recommend filing your report, mirroring as much of the information as possible from the consumer's report, and providing clarifying information in Section H10 of Form 3500A.  Filing never constitutes an admission that the manufacturer or their product caused or contributed to the event.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

Is there a way to respond to a MedWatch report submitted by a patient?

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

As others have noted, MedWatch reports are not always filed with noble intent, and I've seen reports filed by hospitals to falsely imply a device problem in an effort to hide medical malpractice.  I've seen personal injury lawyers behind them as well (they love to claim something was a "sentinel event").   And, of course, companies blaming each other (e.g., manufacturer blaming installer).   

Unless you conclude something is reportable, I agree with the other commenters that your obligation is to process it as a compliant and document what you find, including off-label uses, failure to heed warnings, etc.   But there is no way to respond to, correct, or amend a Medwatch filed by anyone else.    My advice was typically to process the complaint internally and, assuming nothing reportable, wait and see whether the FDA follows up with a question on it, at which point you'll have the opportunity to correct or otherwise respond.   And while the form does say that it's not an admission, personal injury lawyers try to use them to bolster their cases, such as to allege that the company was aware of a problem.


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Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361
------------------------------

Original Message:
Sent: 20-Mar-2018 14:22
From: Bobbi Siddoway
Subject: MedWatch Reports

Is there a way to respond to a MedWatch report submitted by a patient?

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

I offer a word of caution here.

If, on the surface the complaint looks like it might be reportable, then the manufacturer needs to open an MDR Event File. If the event is not reportable, that decision is made by a qualified person and the decision, with supporting evidence, must be in the MDR Event File, not the complaint file.

The complaint file and the MDR Event File can be linked or even be the same file. However, if they are the same, then document this explicitly.

There are Warning Letters to manufacturers who did not correctly document the decision not to file.

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Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 21-Mar-2018 20:15
From: Roger Cepeda
Subject: MedWatch Reports

As others have noted, MedWatch reports are not always filed with noble intent, and I've seen reports filed by hospitals to falsely imply a device problem in an effort to hide medical malpractice.  I've seen personal injury lawyers behind them as well (they love to claim something was a "sentinel event").   And, of course, companies blaming each other (e.g., manufacturer blaming installer).

Unless you conclude something is reportable, I agree with the other commenters that your obligation is to process it as a compliant and document what you find, including off-label uses, failure to heed warnings, etc.   But there is no way to respond to, correct, or amend a Medwatch filed by anyone else.    My advice was typically to process the complaint internally and, assuming nothing reportable, wait and see whether the FDA follows up with a question on it, at which point you'll have the opportunity to correct or otherwise respond.   And while the form does say that it's not an admission, personal injury lawyers try to use them to bolster their cases, such as to allege that the company was aware of a problem.


------------------------------
Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361

Original Message:
Sent: 20-Mar-2018 14:22
From: Bobbi Siddoway
Subject: MedWatch Reports

Is there a way to respond to a MedWatch report submitted by a patient?

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

Thank you everyone!  Here is a little clarification.  The FDA sent us a letter with the MedWatch report attached stating that if we were unaware of this event and if our investigation deems it to be a MDR to file an MDR.  It is definitely NOT an MDR.  The concerning thing is that there is no information regarding the individual who filed the report and they specifically asked the FDA for clarification which they are not going to get.  I have been unable to find a way to respond to the MedWatch report to assist the individual and to clarify that what they are stating is not in anyway correct.

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

Original Message:
Sent: 20-Mar-2018 14:22
From: Bobbi Siddoway
Subject: MedWatch Reports

Is there a way to respond to a MedWatch report submitted by a patient?

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

Do your procedures mention the number of good faith attempts to communicate with customer/end user to obtain more information on the complaint? if so, the best you can do is to try to reach them with the info you have and document if you don't get a response.

------------------------------
Vidyalakshmi Jayaraman
Marlborough MA
United States
------------------------------

Original Message:
Sent: 22-Mar-2018 09:28
From: Bobbi Siddoway
Subject: MedWatch Reports

Thank you everyone!  Here is a little clarification.  The FDA sent us a letter with the MedWatch report attached stating that if we were unaware of this event and if our investigation deems it to be a MDR to file an MDR.  It is definitely NOT an MDR.  The concerning thing is that there is no information regarding the individual who filed the report and they specifically asked the FDA for clarification which they are not going to get.  I have been unable to find a way to respond to the MedWatch report to assist the individual and to clarify that what they are stating is not in anyway correct.

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States

Original Message:
Sent: 20-Mar-2018 14:22
From: Bobbi Siddoway
Subject: MedWatch Reports

Is there a way to respond to a MedWatch report submitted by a patient?

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------

Original Message------

Do your procedures mention the number of good faith attempts to communicate with customer/end user to obtain more information on the complaint? if so, the best you can do is to try to reach them with the info you have and document if you don't get a response.

------------------------------
Vidyalakshmi Jayaraman
Marlborough MA
United States
------------------------------

You need to carefully document the fact that this is not reportable.

First, it is a complaint, so you need a complaint record under 820.198. Because of the way it came in, you should, in the complaint, system, consider it potentially reportable. This means, a designated individual should investigate. Ensure that your complaint records include the data elements from 820.198(e) and from 820.198(d).

Be sure you have a designated an individual, defined the competence requirements for that individual, and have the records to support the individual's competence.

You also need to open an MDR Event File under 803.18. Since you have concluded the event is not reportable then you must document the reason as required by 803.20(c)(2). The documented reason must be in the MDR Event File.

The person making the decision that this is not reportable must be qualified to make a medical judgement. Be sure you have identified the person, defined the competence requirements for that person, and have the records to support the person's competence.

I have no doubt that at your next routine inspection, the FDA Investigator will want to know how you handled it. If you don't have all of these records, then you will most likely receive a Warning Letter.

------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 22-Mar-2018 09:28
From: Bobbi Siddoway
Subject: MedWatch Reports

Thank you everyone!  Here is a little clarification.  The FDA sent us a letter with the MedWatch report attached stating that if we were unaware of this event and if our investigation deems it to be a MDR to file an MDR.  It is definitely NOT an MDR.  The concerning thing is that there is no information regarding the individual who filed the report and they specifically asked the FDA for clarification which they are not going to get.  I have been unable to find a way to respond to the MedWatch report to assist the individual and to clarify that what they are stating is not in anyway correct.

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States

Original Message:
Sent: 20-Mar-2018 14:22
From: Bobbi Siddoway
Subject: MedWatch Reports

Is there a way to respond to a MedWatch report submitted by a patient?

------------------------------
Bobbi Siddoway
Regulatory Specialist
Salt Lake City UT
United States
------------------------------