Regulatory Open Forum

Because there was patient harm and your device was involved, then it is reportable to FDA under Part 803. It may also be reportable in other regions.

Since your IFU is silent on use with an MRI machine, then it is not off label use.

You should have MRI information in the IFU. Also, this is one of the fields in GUDID, so you need to see how you responded and update it. Revise the IFU to include the MRI information. Use the language from the standard cited for the GUDID.

I recommend that you stop shipping the device until you have a revised IFU. In addition, you should notify all current users of the device about the problem. When you send the letter to users you should also report to FDA under Part 806.

Part 806 says you can combine the Part 806 report with the Part 803 report. Don't do it! File separate reports. Submit both reports using eSubmitter.

Changing the IFU is a design change under 820.30. Be sure you update the ISO 14971:2007 risk management file.

Because there was patient harm and your device was involved, then it is reportable to FDA under Part 803. It may also be reportable in other regions.

Since your IFU is silent on use with an MRI machine, then it is not off label use.

You should have MRI information in the IFU. Also, this is one of the fields in GUDID, so you need to see how you responded and update it. Revise the IFU to include the MRI information. Use the language from the standard cited for the GUDID.

I recommend that you stop shipping the device until you have a revised IFU. In addition, you should notify all current users of the device about the problem. When you send the letter to users you should also report to FDA under Part 806.

Part 806 says you can combine the Part 806 report with the Part 803 report. Don't do it! File separate reports. Submit both reports using eSubmitter.

Changing the IFU is a design change under 820.30. Be sure you update the ISO 14971:2007 risk management file.

Part 803 doesn't not have a differentiation between serious and nonserious injury. The injury described in the original post must be reported under Part 803.

In addition, as I described, the manufacturer must take a number of actions.

This is a complaint under 820.198

This is an MDR reportable under 820.198 and Part 803

Investigate the complaint under 820.198 and Part 803

Initiate a corrective action under 820.100

Revise the IFU as a design change under 820.30 for MR compatibility

Update the ISO 14971:2007 risk management file

Review the GUDID submission for MR compatibility and revise is necessary

Send new IFUs to current customers

Stop shipment until there is a new IFU available

Submit the IFU change to FDA as a correction under Part 806

Determine if the IFU requires a new 510(k) under Part 807 (use the guidance document)

It is very important that the manufacturer does not diminish the significance of this event. The consequences are a Warning Letter from FDA. More significantly, the manufacturer is now facing a product liability lawsuit (which may not have been filed yet). The defense includes recognizing the problem and taking immediate action to prevent it from ever happening again.

I often work as an expert witness in these kinds of lawsuits.

Because there was patient harm and your device was involved, then it is reportable to FDA under Part 803. It may also be reportable in other regions.

Since your IFU is silent on use with an MRI machine, then it is not off label use.

You should have MRI information in the IFU. Also, this is one of the fields in GUDID, so you need to see how you responded and update it. Revise the IFU to include the MRI information. Use the language from the standard cited for the GUDID.

I recommend that you stop shipping the device until you have a revised IFU. In addition, you should notify all current users of the device about the problem. When you send the letter to users you should also report to FDA under Part 806.

Part 806 says you can combine the Part 806 report with the Part 803 report. Don't do it! File separate reports. Submit both reports using eSubmitter.

Changing the IFU is a design change under 820.30. Be sure you update the ISO 14971:2007 risk management file.

Part 803 doesn't not have a differentiation between serious and nonserious injury. The injury described in the original post must be reported under Part 803.

In addition, as I described, the manufacturer must take a number of actions.

This is a complaint under 820.198

This is an MDR reportable under 820.198 and Part 803

Investigate the complaint under 820.198 and Part 803

Initiate a corrective action under 820.100

Revise the IFU as a design change under 820.30 for MR compatibility

Update the ISO 14971:2007 risk management file

Review the GUDID submission for MR compatibility and revise is necessary

Send new IFUs to current customers

Stop shipment until there is a new IFU available

Submit the IFU change to FDA as a correction under Part 806

Determine if the IFU requires a new 510(k) under Part 807 (use the guidance document)

It is very important that the manufacturer does not diminish the significance of this event. The consequences are a Warning Letter from FDA. More significantly, the manufacturer is now facing a product liability lawsuit (which may not have been filed yet). The defense includes recognizing the problem and taking immediate action to prevent it from ever happening again.

I often work as an expert witness in these kinds of lawsuits.

Because there was patient harm and your device was involved, then it is reportable to FDA under Part 803. It may also be reportable in other regions.

Since your IFU is silent on use with an MRI machine, then it is not off label use.

You should have MRI information in the IFU. Also, this is one of the fields in GUDID, so you need to see how you responded and update it. Revise the IFU to include the MRI information. Use the language from the standard cited for the GUDID.

I recommend that you stop shipping the device until you have a revised IFU. In addition, you should notify all current users of the device about the problem. When you send the letter to users you should also report to FDA under Part 806.

Part 806 says you can combine the Part 806 report with the Part 803 report. Don't do it! File separate reports. Submit both reports using eSubmitter.

Changing the IFU is a design change under 820.30. Be sure you update the ISO 14971:2007 risk management file.

OOPS!

You are correct, Part 803 does state serious injury.

A careful reading of the definition would suggest that some burns are not serious injuries. For example, if I were to touch a hot surface of a medical device, receive a first degree burn on a fingertip and treat it myself, that is probably not a serious injury.

However, I deal with cases where companies try to draw the line. There are Warning Letters to companies for failure to report burns.

In this regard, I'm very conservative. I have never seen a Warning Letter for over reporting, but many for under reporting. My advice is always, "If in doubt, report". In fact, I urge people to report anytime there is patient or customer involvement of any harm of any magnitude.

OOPS!

You are correct, Part 803 does state serious injury.

A careful reading of the definition would suggest that some burns are not serious injuries. For example, if I were to touch a hot surface of a medical device, receive a first degree burn on a fingertip and treat it myself, that is probably not a serious injury.

However, I deal with cases where companies try to draw the line. There are Warning Letters to companies for failure to report burns.

In this regard, I'm very conservative. I have never seen a Warning Letter for over reporting, but many for under reporting. My advice is always, "If in doubt, report". In fact, I urge people to report anytime there is patient or customer involvement of any harm of any magnitude.

Part 803 doesn't not have a differentiation between serious and nonserious injury. The injury described in the original post must be reported under Part 803.

In addition, as I described, the manufacturer must take a number of actions.

This is a complaint under 820.198

This is an MDR reportable under 820.198 and Part 803

Investigate the complaint under 820.198 and Part 803

Initiate a corrective action under 820.100

Revise the IFU as a design change under 820.30 for MR compatibility

Update the ISO 14971:2007 risk management file

Review the GUDID submission for MR compatibility and revise is necessary

Send new IFUs to current customers

Stop shipment until there is a new IFU available

Submit the IFU change to FDA as a correction under Part 806

Determine if the IFU requires a new 510(k) under Part 807 (use the guidance document)

It is very important that the manufacturer does not diminish the significance of this event. The consequences are a Warning Letter from FDA. More significantly, the manufacturer is now facing a product liability lawsuit (which may not have been filed yet). The defense includes recognizing the problem and taking immediate action to prevent it from ever happening again.

I often work as an expert witness in these kinds of lawsuits.

Because there was patient harm and your device was involved, then it is reportable to FDA under Part 803. It may also be reportable in other regions.

Since your IFU is silent on use with an MRI machine, then it is not off label use.

You should have MRI information in the IFU. Also, this is one of the fields in GUDID, so you need to see how you responded and update it. Revise the IFU to include the MRI information. Use the language from the standard cited for the GUDID.

I recommend that you stop shipping the device until you have a revised IFU. In addition, you should notify all current users of the device about the problem. When you send the letter to users you should also report to FDA under Part 806.

Part 806 says you can combine the Part 806 report with the Part 803 report. Don't do it! File separate reports. Submit both reports using eSubmitter.

Changing the IFU is a design change under 820.30. Be sure you update the ISO 14971:2007 risk management file.

OOPS!

You are correct, Part 803 does state serious injury.

A careful reading of the definition would suggest that some burns are not serious injuries. For example, if I were to touch a hot surface of a medical device, receive a first degree burn on a fingertip and treat it myself, that is probably not a serious injury.

However, I deal with cases where companies try to draw the line. There are Warning Letters to companies for failure to report burns.

In this regard, I'm very conservative. I have never seen a Warning Letter for over reporting, but many for under reporting. My advice is always, "If in doubt, report". In fact, I urge people to report anytime there is patient or customer involvement of any harm of any magnitude.

Part 803 doesn't not have a differentiation between serious and nonserious injury. The injury described in the original post must be reported under Part 803.

In addition, as I described, the manufacturer must take a number of actions.

This is a complaint under 820.198

This is an MDR reportable under 820.198 and Part 803

Investigate the complaint under 820.198 and Part 803

Initiate a corrective action under 820.100

Revise the IFU as a design change under 820.30 for MR compatibility

Update the ISO 14971:2007 risk management file

Review the GUDID submission for MR compatibility and revise is necessary

Send new IFUs to current customers

Stop shipment until there is a new IFU available

Submit the IFU change to FDA as a correction under Part 806

Determine if the IFU requires a new 510(k) under Part 807 (use the guidance document)

It is very important that the manufacturer does not diminish the significance of this event. The consequences are a Warning Letter from FDA. More significantly, the manufacturer is now facing a product liability lawsuit (which may not have been filed yet). The defense includes recognizing the problem and taking immediate action to prevent it from ever happening again.

I often work as an expert witness in these kinds of lawsuits.

Because there was patient harm and your device was involved, then it is reportable to FDA under Part 803. It may also be reportable in other regions.

Since your IFU is silent on use with an MRI machine, then it is not off label use.

You should have MRI information in the IFU. Also, this is one of the fields in GUDID, so you need to see how you responded and update it. Revise the IFU to include the MRI information. Use the language from the standard cited for the GUDID.

I recommend that you stop shipping the device until you have a revised IFU. In addition, you should notify all current users of the device about the problem. When you send the letter to users you should also report to FDA under Part 806.

Part 806 says you can combine the Part 806 report with the Part 803 report. Don't do it! File separate reports. Submit both reports using eSubmitter.

Changing the IFU is a design change under 820.30. Be sure you update the ISO 14971:2007 risk management file.

Part 803 doesn't not have a differentiation between serious and nonserious injury. The injury described in the original post must be reported under Part 803.

In addition, as I described, the manufacturer must take a number of actions.

This is a complaint under 820.198

This is an MDR reportable under 820.198 and Part 803

Investigate the complaint under 820.198 and Part 803

Initiate a corrective action under 820.100

Revise the IFU as a design change under 820.30 for MR compatibility

Update the ISO 14971:2007 risk management file

Review the GUDID submission for MR compatibility and revise is necessary

Send new IFUs to current customers

Stop shipment until there is a new IFU available

Submit the IFU change to FDA as a correction under Part 806

Determine if the IFU requires a new 510(k) under Part 807 (use the guidance document)

It is very important that the manufacturer does not diminish the significance of this event. The consequences are a Warning Letter from FDA. More significantly, the manufacturer is now facing a product liability lawsuit (which may not have been filed yet). The defense includes recognizing the problem and taking immediate action to prevent it from ever happening again.

I often work as an expert witness in these kinds of lawsuits.

Because there was patient harm and your device was involved, then it is reportable to FDA under Part 803. It may also be reportable in other regions.

Since your IFU is silent on use with an MRI machine, then it is not off label use.

You should have MRI information in the IFU. Also, this is one of the fields in GUDID, so you need to see how you responded and update it. Revise the IFU to include the MRI information. Use the language from the standard cited for the GUDID.

I recommend that you stop shipping the device until you have a revised IFU. In addition, you should notify all current users of the device about the problem. When you send the letter to users you should also report to FDA under Part 806.

Part 806 says you can combine the Part 806 report with the Part 803 report. Don't do it! File separate reports. Submit both reports using eSubmitter.

Changing the IFU is a design change under 820.30. Be sure you update the ISO 14971:2007 risk management file.