Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All,

I hope you are well.  What do I do if the sales rep that reported a "complaint" will not provide me with any information?  I have made a dozen attempts to get information from the rep but he is uncooperative.   The story and "facts" keep changing, fortunately to lessening severity.  The "complaint" does not rise to the level of serious injury or death; it has been reviewed by a clinician and determined to be a minor injury.  How do I close this out, if I can at all?

Hello,

This situation can be extremely frustrating.  Hopefully, you have documented all information and attempts to obtain additional information..?  Can you reach out to the facility directly to get more information? 

From what you have described, it sounds like it is reportable.  You will complete an MDR report based on the information you have and send supplemental reports as new information is received.  This should be captured in your complaint handling system and also PMS including Risk Management and CER as applicable.  Your sales team also needs training or a refresher on complaint handling and reportability.  

Good luck!

------------------------------
Gretchen Upton
RAC, CQA, CCRP
QA/RA consultant
San Antonio, TX
------------------------------

Original Message:
Sent: 24-Sep-2021 09:23
From: Anonymous Member
Subject: Unresponsive Complainant

This message was posted by a user wishing to remain anonymous

Hello All,

I hope you are well.  What do I do if the sales rep that reported a "complaint" will not provide me with any information?  I have made a dozen attempts to get information from the rep but he is uncooperative.   The story and "facts" keep changing, fortunately to lessening severity.  The "complaint" does not rise to the level of serious injury or death; it has been reviewed by a clinician and determined to be a minor injury.  How do I close this out, if I can at all?

Hi Anon

Sounds like you have three problems to resolve.

If a sales rep is unwilling to speak with you in a reasonable way, there is probably something wrong in the communication channel. You may need to involve another person there to help understand what's not working and how it might be repaired or improved for the future.

If you determine the incident is not reportable, try to document the rationale very clearly. The clinician's determination that it appears to be a minor injury is important. Also important is what information the clinician reviewed to reach that conclusion, considering that you seem to have heard conflicting descriptions of the problem.

Investigation of the problem, following your complaint investigation procedures, is usually commensurate with some judgment around the potential risks associated with the apparent problem. This one person who said that something might have happened somewhere is not the only possible source of information. You might have a clue as to which other people may have been involved in the incident. If you know which product(s) may have been involved, you can research their history for any similar events or plausible explanations for what may have happened. The documentation of the investigation should also be clear about what's known and unknown, what research attempts were made, and what conclusions could or could not be drawn.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 25-Sep-2021 12:46
From: Gretchen Upton
Subject: Unresponsive Complainant

Hello,

This situation can be extremely frustrating.  Hopefully, you have documented all information and attempts to obtain additional information..?  Can you reach out to the facility directly to get more information?

From what you have described, it sounds like it is reportable.  You will complete an MDR report based on the information you have and send supplemental reports as new information is received.  This should be captured in your complaint handling system and also PMS including Risk Management and CER as applicable.  Your sales team also needs training or a refresher on complaint handling and reportability.

Good luck!

------------------------------
Gretchen Upton
RAC, CQA, CCRP
QA/RA consultant
San Antonio, TX

Original Message:
Sent: 24-Sep-2021 09:23
From: Anonymous Member
Subject: Unresponsive Complainant

This message was posted by a user wishing to remain anonymous

Hello All,

I hope you are well.  What do I do if the sales rep that reported a "complaint" will not provide me with any information?  I have made a dozen attempts to get information from the rep but he is uncooperative.   The story and "facts" keep changing, fortunately to lessening severity.  The "complaint" does not rise to the level of serious injury or death; it has been reviewed by a clinician and determined to be a minor injury.  How do I close this out, if I can at all?

Good Day....

I specifically asked an FDA inspector several years ago how to handle this situation, however, it did not involve a sales rep, but the actual hospital/home care facility.  He said to document at least 5 attempts to obtain the information and then close the case once the investigation is completed based on the limited information provided.

 I would document each attempt you made and the changing information that was provided.  After you have accumulated 5 attempts, document that you are closing the case based on lack of available information after 5 attempts since you indicate the investigation was performed and is completed with no serious injury or death.

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 24-Sep-2021 09:23
From: Anonymous Member
Subject: Unresponsive Complainant

This message was posted by a user wishing to remain anonymous

Hello All,

I hope you are well.  What do I do if the sales rep that reported a "complaint" will not provide me with any information?  I have made a dozen attempts to get information from the rep but he is uncooperative.   The story and "facts" keep changing, fortunately to lessening severity.  The "complaint" does not rise to the level of serious injury or death; it has been reviewed by a clinician and determined to be a minor injury.  How do I close this out, if I can at all?

When I worked in research at the VA we implanted a nerve cuff percutaneously for a study of nerve stim with the idea to explant it 5 years later. I think there were only 10 study participants who were recruited and met the very unique criteria requirements simulating military vets who lost arms at a certain distance from the elbow to the wrist. 

Well, apparently one of the participants decided to move out of the USA to Mexico and retire and spend all his time fishing. He refused all calls, letters, emails, texts, etc to communicate with the research team. 

We called on FDA for assistance on how to proceed. One of the study nurses found his Facebook page. The FDA ruled we could use his social media posting as evidence of his health (Out fishing on a boat in the ocean) in lieu of direct contact with the subject. I left shortly after this so I don't know how it closed out but the FDA is very open to creative investigations to determine how users are doing despite lack of feedback directly.

I often wonder how this subject is doing and how he explains the electrodes coming out of his skin to other people.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 27-Sep-2021 07:53
From: D Michelle Williams
Subject: Unresponsive Complainant

Good Day....

I specifically asked an FDA inspector several years ago how to handle this situation, however, it did not involve a sales rep, but the actual hospital/home care facility.  He said to document at least 5 attempts to obtain the information and then close the case once the investigation is completed based on the limited information provided.

 I would document each attempt you made and the changing information that was provided.  After you have accumulated 5 attempts, document that you are closing the case based on lack of available information after 5 attempts since you indicate the investigation was performed and is completed with no serious injury or death.

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 24-Sep-2021 09:23
From: Anonymous Member
Subject: Unresponsive Complainant

This message was posted by a user wishing to remain anonymous

Hello All,

I hope you are well.  What do I do if the sales rep that reported a "complaint" will not provide me with any information?  I have made a dozen attempts to get information from the rep but he is uncooperative.   The story and "facts" keep changing, fortunately to lessening severity.  The "complaint" does not rise to the level of serious injury or death; it has been reviewed by a clinician and determined to be a minor injury.  How do I close this out, if I can at all?

I will note though, that since this case involves a sales rep who presumably works for the company, there will be an expectation that he follows company policy to respond. So you probably can't just make several attempts and call it good. You most likely need to involve sales management or other executive management.

Ginger

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

Original Message:
Sent: 27-Sep-2021 07:53
From: D Michelle Williams
Subject: Unresponsive Complainant

Good Day....

I specifically asked an FDA inspector several years ago how to handle this situation, however, it did not involve a sales rep, but the actual hospital/home care facility.  He said to document at least 5 attempts to obtain the information and then close the case once the investigation is completed based on the limited information provided.

 I would document each attempt you made and the changing information that was provided.  After you have accumulated 5 attempts, document that you are closing the case based on lack of available information after 5 attempts since you indicate the investigation was performed and is completed with no serious injury or death.

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 24-Sep-2021 09:23
From: Anonymous Member
Subject: Unresponsive Complainant

This message was posted by a user wishing to remain anonymous

Hello All,

I hope you are well.  What do I do if the sales rep that reported a "complaint" will not provide me with any information?  I have made a dozen attempts to get information from the rep but he is uncooperative.   The story and "facts" keep changing, fortunately to lessening severity.  The "complaint" does not rise to the level of serious injury or death; it has been reviewed by a clinician and determined to be a minor injury.  How do I close this out, if I can at all?

Original Message:
Sent: 9/28/2021 10:52:00 AM
From: Ginger Glaser
Subject: RE: Unresponsive Complainant

I will note though, that since this case involves a sales rep who presumably works for the company, there will be an expectation that he follows company policy to respond. So you probably can't just make several attempts and call it good. You most likely need to involve sales management or other executive management.

Ginger

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

Original Message:
Sent: 27-Sep-2021 07:53
From: D Michelle Williams
Subject: Unresponsive Complainant

Good Day....

I specifically asked an FDA inspector several years ago how to handle this situation, however, it did not involve a sales rep, but the actual hospital/home care facility.  He said to document at least 5 attempts to obtain the information and then close the case once the investigation is completed based on the limited information provided.

 I would document each attempt you made and the changing information that was provided.  After you have accumulated 5 attempts, document that you are closing the case based on lack of available information after 5 attempts since you indicate the investigation was performed and is completed with no serious injury or death.

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 24-Sep-2021 09:23
From: Anonymous Member
Subject: Unresponsive Complainant

This message was posted by a user wishing to remain anonymous

Hello All,

I hope you are well.  What do I do if the sales rep that reported a "complaint" will not provide me with any information?  I have made a dozen attempts to get information from the rep but he is uncooperative.   The story and "facts" keep changing, fortunately to lessening severity.  The "complaint" does not rise to the level of serious injury or death; it has been reviewed by a clinician and determined to be a minor injury.  How do I close this out, if I can at all?

Good Day Ted/Ginger,

What would be different if all your sales reps are independent sales rep and not employees of your company?  How would you control them since they only receive a commission?

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 28-Sep-2021 11:04
From: Ted Heise
Subject: Unresponsive Complainant

 

 

 

Ginger, I'm really glad you brought that out.  It definitely calls for a different approach when the source is internal to the company.

 

Best regards,

 

Ted

 

 

 

Original Message:
Sent: 9/28/2021 10:52:00 AM
From: Ginger Glaser
Subject: RE: Unresponsive Complainant

I will note though, that since this case involves a sales rep who presumably works for the company, there will be an expectation that he follows company policy to respond. So you probably can't just make several attempts and call it good. You most likely need to involve sales management or other executive management.

Ginger

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

Original Message:
Sent: 27-Sep-2021 07:53
From: D Michelle Williams
Subject: Unresponsive Complainant

Good Day....

I specifically asked an FDA inspector several years ago how to handle this situation, however, it did not involve a sales rep, but the actual hospital/home care facility.  He said to document at least 5 attempts to obtain the information and then close the case once the investigation is completed based on the limited information provided.

 I would document each attempt you made and the changing information that was provided.  After you have accumulated 5 attempts, document that you are closing the case based on lack of available information after 5 attempts since you indicate the investigation was performed and is completed with no serious injury or death.

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 24-Sep-2021 09:23
From: Anonymous Member
Subject: Unresponsive Complainant

This message was posted by a user wishing to remain anonymous

Hello All,

I hope you are well.  What do I do if the sales rep that reported a "complaint" will not provide me with any information?  I have made a dozen attempts to get information from the rep but he is uncooperative.   The story and "facts" keep changing, fortunately to lessening severity.  The "complaint" does not rise to the level of serious injury or death; it has been reviewed by a clinician and determined to be a minor injury.  How do I close this out, if I can at all?

Original Message:
Sent: 9/28/2021 12:15:00 PM
From: D Michelle Williams
Subject: RE: Unresponsive Complainant

Good Day Ted/Ginger,

What would be different if all your sales reps are independent sales rep and not employees of your company?  How would you control them since they only receive a commission?

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 28-Sep-2021 11:04
From: Ted Heise
Subject: Unresponsive Complainant

 

 

 

Ginger, I'm really glad you brought that out.  It definitely calls for a different approach when the source is internal to the company.

 

Best regards,

 

Ted

 

 

 

Original Message:
Sent: 9/28/2021 10:52:00 AM
From: Ginger Glaser
Subject: RE: Unresponsive Complainant

I will note though, that since this case involves a sales rep who presumably works for the company, there will be an expectation that he follows company policy to respond. So you probably can't just make several attempts and call it good. You most likely need to involve sales management or other executive management.

Ginger

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

Original Message:
Sent: 27-Sep-2021 07:53
From: D Michelle Williams
Subject: Unresponsive Complainant

Good Day....

I specifically asked an FDA inspector several years ago how to handle this situation, however, it did not involve a sales rep, but the actual hospital/home care facility.  He said to document at least 5 attempts to obtain the information and then close the case once the investigation is completed based on the limited information provided.

 I would document each attempt you made and the changing information that was provided.  After you have accumulated 5 attempts, document that you are closing the case based on lack of available information after 5 attempts since you indicate the investigation was performed and is completed with no serious injury or death.

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 24-Sep-2021 09:23
From: Anonymous Member
Subject: Unresponsive Complainant

This message was posted by a user wishing to remain anonymous

Hello All,

I hope you are well.  What do I do if the sales rep that reported a "complaint" will not provide me with any information?  I have made a dozen attempts to get information from the rep but he is uncooperative.   The story and "facts" keep changing, fortunately to lessening severity.  The "complaint" does not rise to the level of serious injury or death; it has been reviewed by a clinician and determined to be a minor injury.  How do I close this out, if I can at all?

That is a good question! I would think independent sales reps would be treated a bit like distributors. When I had this happen with an international distributor (at a time when company was dealing with a WL no less) the FDA inspector looked at the following:

- did the contract we had with the distributor include requirement to report complaints and provide follow up information,
- did we make numerous attempts to get said information,
- did we warn in writing that we would terminate the agreement if the behavior continued?
- was this systematic across all our distributors (trying to determine if company actually encouraged this and in this case this was a one off)

With those things in place, he was comfortable that we eventually closed the complaint file.

Ginger

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

Original Message:
Sent: 28-Sep-2021 12:14
From: D Michelle Williams
Subject: Unresponsive Complainant

Good Day Ted/Ginger,

What would be different if all your sales reps are independent sales rep and not employees of your company?  How would you control them since they only receive a commission?

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 28-Sep-2021 11:04
From: Ted Heise
Subject: Unresponsive Complainant

 

 

 

Ginger, I'm really glad you brought that out.  It definitely calls for a different approach when the source is internal to the company.

 

Best regards,

 

Ted

 

 

 

Original Message:
Sent: 9/28/2021 10:52:00 AM
From: Ginger Glaser
Subject: RE: Unresponsive Complainant

I will note though, that since this case involves a sales rep who presumably works for the company, there will be an expectation that he follows company policy to respond. So you probably can't just make several attempts and call it good. You most likely need to involve sales management or other executive management.

Ginger

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

Original Message:
Sent: 27-Sep-2021 07:53
From: D Michelle Williams
Subject: Unresponsive Complainant

Good Day....

I specifically asked an FDA inspector several years ago how to handle this situation, however, it did not involve a sales rep, but the actual hospital/home care facility.  He said to document at least 5 attempts to obtain the information and then close the case once the investigation is completed based on the limited information provided.

 I would document each attempt you made and the changing information that was provided.  After you have accumulated 5 attempts, document that you are closing the case based on lack of available information after 5 attempts since you indicate the investigation was performed and is completed with no serious injury or death.

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 24-Sep-2021 09:23
From: Anonymous Member
Subject: Unresponsive Complainant

This message was posted by a user wishing to remain anonymous

Hello All,

I hope you are well.  What do I do if the sales rep that reported a "complaint" will not provide me with any information?  I have made a dozen attempts to get information from the rep but he is uncooperative.   The story and "facts" keep changing, fortunately to lessening severity.  The "complaint" does not rise to the level of serious injury or death; it has been reviewed by a clinician and determined to be a minor injury.  How do I close this out, if I can at all?

In my past experience involving complaint handling this is a relatively common occurrence. Companies typically have a due diligence procedure for complaints/adverse events specifying the types of communication, number of attempts, and amount of time before such a complaint can be closed due to lack of response. Those attempts are documented in the complaint record. I'd recommend including this in a procedure which would be available upon inspection.

------------------------------
Jonathan Amaya-Hodges
Sr. Principal Consultant
jamaya-hodges@suttonscreek.com
Suttons Creek, Inc.
United States
https://suttonscreek.com/
------------------------------

Original Message:
Sent: 24-Sep-2021 09:23
From: Anonymous Member
Subject: Unresponsive Complainant

This message was posted by a user wishing to remain anonymous

Hello All,

I hope you are well.  What do I do if the sales rep that reported a "complaint" will not provide me with any information?  I have made a dozen attempts to get information from the rep but he is uncooperative.   The story and "facts" keep changing, fortunately to lessening severity.  The "complaint" does not rise to the level of serious injury or death; it has been reviewed by a clinician and determined to be a minor injury.  How do I close this out, if I can at all?