Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Good Day!

I am interested in opinions on the following scenario as to report or not to report an event to the FDA:

Sales Director reaches out to a hospital to inquire about an in-service for their manufacturer's product.  The nurse specialist responds to email and adds that she has some questions related to pt skin integrity.  The nurse states they are advocating placing pt directly on the product but they are concerned since they have had a few skin injuries lately.  The nurse added that they purchase through another source and purchase a private label version.

Later the nurse provides information regarding 2 specific injuries involving skin tears, blistering, and redness.  The nurse describes the products by type/description but does not have product numbers; she only has surgical information and the notes about the pt during the surgery.  The facility once ordered the specific products about 8 years ago using the product descriptions provided.  The nurse acknowledges that no MEDSUN report was filed as of yet.  Nurse is asked for contact in risk management.

Contact is made with the Risk Management Consultant at the facility.  This person states they are still gathering information; the specific products are unknown to this person.  Follow-up with this person yields that the facility believes the injuries were the result of compromised patient skin integrity vs procedure or products and still investigating.  The person indicates that they will most likely do nothing due to the poor skin integrity of the patient...basically, it would have happened on any product or without the product due to the pt and length of surgery.  Over next couple weeks, contact is attempted with the Risk Management Consultant but emails and phone calls are not returned.

So:
1. If product is private label, then if an adverse report is done it would be by the name listed on the label.
2. Since facility says they don't consider it an injury, an MDR is not filed by manufacturer.
3. Since unsure product is manufacturers and not private label, an MDR is not filed by the manufacturer.
4. No other similar manufacturers are reporting injuries involving poor skin integrity, an MDR is not filed by the manufacturer.

For 1, correct statement because it is the seller's responsibility to file according to FDA (confirmed previously)
For 2, opinions requested since one of the pt codes is skin integrity
For 3, opinions requested since one of the conclusion codes is not our device
For 4, opinions requested...basic thought is this manufacturer's product out performs the competition in all studies and the competition has no MDRs so no report is required because they aren't reporting these types of injuries

Your experience/opinions are greatly appreciated.

This is an interesting question, does anyone have any experience or comments on this?

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D Michelle Williams
VP - Operations
United States
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Original Message:
Sent: 20-Jul-2018 08:32
From: Anonymous Member
Subject: Adverse Event Reporting - File or do not file

This message was posted by a user wishing to remain anonymous

Good Day!

I am interested in opinions on the following scenario as to report or not to report an event to the FDA:

Sales Director reaches out to a hospital to inquire about an in-service for their manufacturer's product.  The nurse specialist responds to email and adds that she has some questions related to pt skin integrity.  The nurse states they are advocating placing pt directly on the product but they are concerned since they have had a few skin injuries lately.  The nurse added that they purchase through another source and purchase a private label version.

Later the nurse provides information regarding 2 specific injuries involving skin tears, blistering, and redness.  The nurse describes the products by type/description but does not have product numbers; she only has surgical information and the notes about the pt during the surgery.  The facility once ordered the specific products about 8 years ago using the product descriptions provided.  The nurse acknowledges that no MEDSUN report was filed as of yet.  Nurse is asked for contact in risk management.

Contact is made with the Risk Management Consultant at the facility.  This person states they are still gathering information; the specific products are unknown to this person.  Follow-up with this person yields that the facility believes the injuries were the result of compromised patient skin integrity vs procedure or products and still investigating.  The person indicates that they will most likely do nothing due to the poor skin integrity of the patient...basically, it would have happened on any product or without the product due to the pt and length of surgery.  Over next couple weeks, contact is attempted with the Risk Management Consultant but emails and phone calls are not returned.

So:
1. If product is private label, then if an adverse report is done it would be by the name listed on the label.
2. Since facility says they don't consider it an injury, an MDR is not filed by manufacturer.
3. Since unsure product is manufacturers and not private label, an MDR is not filed by the manufacturer.
4. No other similar manufacturers are reporting injuries involving poor skin integrity, an MDR is not filed by the manufacturer.

For 1, correct statement because it is the seller's responsibility to file according to FDA (confirmed previously)
For 2, opinions requested since one of the pt codes is skin integrity
For 3, opinions requested since one of the conclusion codes is not our device
For 4, opinions requested...basic thought is this manufacturer's product out performs the competition in all studies and the competition has no MDRs so no report is required because they aren't reporting these types of injuries

Your experience/opinions are greatly appreciated.

​This is definitely an interesting question.

My first thought is that I would dis-regard the rationale for number 4 as I don't ever base my reporting decisions on what other manufacturers seem to be doing (if I know they are doing it a certain way and have documentation to support it, that's a different story, but not based on what I see or don't see in MAUDE).  Also, since the hospital didn't report this situation to this manufacturer at the time it happened and didn't consider it an injury (it just came up because the manf reached out to them about the in-service), it's likely that the hospitals don't report it to any of the manufacturers so they may be unaware of it.

As the original poster has tried to do, it is important to find out if the device is theirs or someone else's.  Are they able to determine that based on date of the surgery?  Is the device a sterile device?  If so, what is the shelf life?  If the hospital last ordered directly from the manufacturer 8 yrs ago, is it possible that the device is still within its valid shelf life?  If not, it's probably safe to assume the device did not come directly from them.  If the device is not sterile or you cannot reasonably justify based on dates, usage rate etc that the device likely did not come from the manufacturer, then I think you need to assume it could have and then need to go through the reporting decisions.

Item number 2 states that the facility doesn't consider it an injury - who at the facility?  Clearly, an injury occurred.  The question is whether that injury 1) meets the definition of serious injury per MDR regs and 2) was caused by the device.  I think you need documented information from the treating physician stating the device did not cause the injury in order to justify not reporting.

Item number 3 goes back to number 1 - if it cannot be reasonably justified that the device is not the manufacturer's, and the event is determined to be reportable, the 'not our device' conclusion code can be used and an explanation of the uncertainty can be provided in the manufacturer narrative box on the MDR form.

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Amy McKinney RAC
Sr Manager, Regulatory Affairs, Interventional Oncology
Fulshear TX
United States
------------------------------

Original Message:
Sent: 31-Jul-2018 07:35
From: D Michelle Williams
Subject: Adverse Event Reporting - File or do not file

This is an interesting question, does anyone have any experience or comments on this?

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

Original Message:
Sent: 20-Jul-2018 08:32
From: Anonymous Member
Subject: Adverse Event Reporting - File or do not file

This message was posted by a user wishing to remain anonymous

Good Day!

I am interested in opinions on the following scenario as to report or not to report an event to the FDA:

Sales Director reaches out to a hospital to inquire about an in-service for their manufacturer's product.  The nurse specialist responds to email and adds that she has some questions related to pt skin integrity.  The nurse states they are advocating placing pt directly on the product but they are concerned since they have had a few skin injuries lately.  The nurse added that they purchase through another source and purchase a private label version.

Later the nurse provides information regarding 2 specific injuries involving skin tears, blistering, and redness.  The nurse describes the products by type/description but does not have product numbers; she only has surgical information and the notes about the pt during the surgery.  The facility once ordered the specific products about 8 years ago using the product descriptions provided.  The nurse acknowledges that no MEDSUN report was filed as of yet.  Nurse is asked for contact in risk management.

Contact is made with the Risk Management Consultant at the facility.  This person states they are still gathering information; the specific products are unknown to this person.  Follow-up with this person yields that the facility believes the injuries were the result of compromised patient skin integrity vs procedure or products and still investigating.  The person indicates that they will most likely do nothing due to the poor skin integrity of the patient...basically, it would have happened on any product or without the product due to the pt and length of surgery.  Over next couple weeks, contact is attempted with the Risk Management Consultant but emails and phone calls are not returned.

So:
1. If product is private label, then if an adverse report is done it would be by the name listed on the label.
2. Since facility says they don't consider it an injury, an MDR is not filed by manufacturer.
3. Since unsure product is manufacturers and not private label, an MDR is not filed by the manufacturer.
4. No other similar manufacturers are reporting injuries involving poor skin integrity, an MDR is not filed by the manufacturer.

For 1, correct statement because it is the seller's responsibility to file according to FDA (confirmed previously)
For 2, opinions requested since one of the pt codes is skin integrity
For 3, opinions requested since one of the conclusion codes is not our device
For 4, opinions requested...basic thought is this manufacturer's product out performs the competition in all studies and the competition has no MDRs so no report is required because they aren't reporting these types of injuries

Your experience/opinions are greatly appreciated.