Regulatory Open Forum

Hello QARA Professionals,

We are Class I (Self declaration) Canada based medical devices manufacturer and shipping devices mainly to US, Canada, Europe, UK, Switzerland, Australia.
Unfortunately, we got a complaint from Canadian customer that he got cut in his body that led to 3-4 stiches. Thank God, there is no death issue or wound is healable.
We never had such issue previously. 

As an expert, what you'd suggest me. 
Should I report to HC as I'm not sure if it matches the serious health deterioration definition.
If yes, then I need to report to Health Canada within 10 days, please correct me if I'm wrong.
Do you know form, which I should use to report HC?

Do I also need to report other regulatory bodies such as MHRA, FDA , EU Regulatory authority, EU-REP, etc.
Please keep in mind, incident occurred in Canada. 

Your guidance would be highly appreciated.

Thank you,

Hello Arslan

A good rule of thumb is - when in doubt, you should report. Having said that, you should look up criteria in Part 803 for FDA requirements. 

From a risk management point of view, you should analyze this incident to see if you should consider recognizing this as a potential harm. You mention that you have not had this issue previously. It is clear though that the patient was hurt requiring medical intervention. It would be good to look closely to see if there was any misuse, including intentional acts and use-errors. Now that you have become aware, it should be treated as foreseeable and reasonable.

I am sure other colleagues here on the forum will offer more tailored advice with respect to reportability. My interest, and expertise is in risk management.

Best regards

Hello QARA Professionals,

We are Class I (Self declaration) Canada based medical devices manufacturer and shipping devices mainly to US, Canada, Europe, UK, Switzerland, Australia.
Unfortunately, we got a complaint from Canadian customer that he got cut in his body that led to 3-4 stiches. Thank God, there is no death issue or wound is healable.
We never had such issue previously. 

As an expert, what you'd suggest me. 
Should I report to HC as I'm not sure if it matches the serious health deterioration definition.
If yes, then I need to report to Health Canada within 10 days, please correct me if I'm wrong.
Do you know form, which I should use to report HC?

Do I also need to report other regulatory bodies such as MHRA, FDA , EU Regulatory authority, EU-REP, etc.
Please keep in mind, incident occurred in Canada. 

Your guidance would be highly appreciated.

Thank you,

Hello Arslan,

I agree that if any doubt or not sure, better to report and have the regulatory agency send a nice friendly note saying thank you for letting us know.  While most regulatory agencies have the definition of serious injury being similar, you would need to look at each of the regulatory requirements to ensure the proper reporting is done according to the definition.  I could not provide any comment if this should be reportable or not without understanding the device type, situation, and how the injury was completely resolved.  However, by some basics of the definitions an injury which required (surgical) intervention would be reportable.  If this happened in Canada, then it would only be reported in Canada.  Almost all regulatory agency serious incident/adverse event reporting would only be done in that country if the event occurred in that specific country.

Hello Arslan

A good rule of thumb is - when in doubt, you should report. Having said that, you should look up criteria in Part 803 for FDA requirements. 

From a risk management point of view, you should analyze this incident to see if you should consider recognizing this as a potential harm. You mention that you have not had this issue previously. It is clear though that the patient was hurt requiring medical intervention. It would be good to look closely to see if there was any misuse, including intentional acts and use-errors. Now that you have become aware, it should be treated as foreseeable and reasonable.

I am sure other colleagues here on the forum will offer more tailored advice with respect to reportability. My interest, and expertise is in risk management.

Best regards

------------------------------
Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/

Original Message:
Sent: 08-Jan-2024 14:20
From: Arslan Rahat
Subject: Incident Reporting to Regulatory Authorities

Hello QARA Professionals,

We are Class I (Self declaration) Canada based medical devices manufacturer and shipping devices mainly to US, Canada, Europe, UK, Switzerland, Australia.
Unfortunately, we got a complaint from Canadian customer that he got cut in his body that led to 3-4 stiches. Thank God, there is no death issue or wound is healable.
We never had such issue previously. 

As an expert, what you'd suggest me. 
Should I report to HC as I'm not sure if it matches the serious health deterioration definition.
If yes, then I need to report to Health Canada within 10 days, please correct me if I'm wrong.
Do you know form, which I should use to report HC?

Do I also need to report other regulatory bodies such as MHRA, FDA , EU Regulatory authority, EU-REP, etc.
Please keep in mind, incident occurred in Canada. 

Your guidance would be highly appreciated.

Thank you,

Hello Arslan

A good rule of thumb is - when in doubt, you should report. Having said that, you should look up criteria in Part 803 for FDA requirements. 

From a risk management point of view, you should analyze this incident to see if you should consider recognizing this as a potential harm. You mention that you have not had this issue previously. It is clear though that the patient was hurt requiring medical intervention. It would be good to look closely to see if there was any misuse, including intentional acts and use-errors. Now that you have become aware, it should be treated as foreseeable and reasonable.

I am sure other colleagues here on the forum will offer more tailored advice with respect to reportability. My interest, and expertise is in risk management.

Best regards

------------------------------
Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/

Original Message:
Sent: 08-Jan-2024 14:20
From: Arslan Rahat
Subject: Incident Reporting to Regulatory Authorities

Hello QARA Professionals,

We are Class I (Self declaration) Canada based medical devices manufacturer and shipping devices mainly to US, Canada, Europe, UK, Switzerland, Australia.
Unfortunately, we got a complaint from Canadian customer that he got cut in his body that led to 3-4 stiches. Thank God, there is no death issue or wound is healable.
We never had such issue previously. 

As an expert, what you'd suggest me. 
Should I report to HC as I'm not sure if it matches the serious health deterioration definition.
If yes, then I need to report to Health Canada within 10 days, please correct me if I'm wrong.
Do you know form, which I should use to report HC?

Do I also need to report other regulatory bodies such as MHRA, FDA , EU Regulatory authority, EU-REP, etc.
Please keep in mind, incident occurred in Canada. 

Your guidance would be highly appreciated.

Thank you,

Hello QARA Professionals,

We are Class I (Self declaration) Canada based medical devices manufacturer and shipping devices mainly to US, Canada, Europe, UK, Switzerland, Australia.
Unfortunately, we got a complaint from Canadian customer that he got cut in his body that led to 3-4 stiches. Thank God, there is no death issue or wound is healable.
We never had such issue previously. 

As an expert, what you'd suggest me. 
Should I report to HC as I'm not sure if it matches the serious health deterioration definition.
If yes, then I need to report to Health Canada within 10 days, please correct me if I'm wrong.
Do you know form, which I should use to report HC?

Do I also need to report other regulatory bodies such as MHRA, FDA , EU Regulatory authority, EU-REP, etc.
Please keep in mind, incident occurred in Canada. 

Your guidance would be highly appreciated.

Thank you,

Hello QARA Professionals,

We are Class I (Self declaration) Canada based medical devices manufacturer and shipping devices mainly to US, Canada, Europe, UK, Switzerland, Australia.
Unfortunately, we got a complaint from Canadian customer that he got cut in his body that led to 3-4 stiches. Thank God, there is no death issue or wound is healable.
We never had such issue previously. 

As an expert, what you'd suggest me. 
Should I report to HC as I'm not sure if it matches the serious health deterioration definition.
If yes, then I need to report to Health Canada within 10 days, please correct me if I'm wrong.
Do you know form, which I should use to report HC?

Do I also need to report other regulatory bodies such as MHRA, FDA , EU Regulatory authority, EU-REP, etc.
Please keep in mind, incident occurred in Canada. 

Your guidance would be highly appreciated.

Thank you,