MDR Reporting - How to interpret requirements for MDR

W

wes77

#1
How to interpret requirements for MDR?

I work for a medical device company, and our distributor sends us a complaint regarding a vascular port.

There is not much information available on the complaint.

Patient develops a rash, one week after implantation of a vascular port, at the site of the port. Patient was referred to a dematologist. Cause of rash is unknown. Nothing more is reported

Several attempts were conducted to get info....nothing more

There is no indication of device malfunction or injury reoccuring if device were to malfunction again. I guess seeing a dermatologist would be some sort of intervention. There is so far a single incident

Is this a MDR reportable? How would FDA view this?

In most cases, should the conservative approach of filing a MDR be the answer.

All advice and suggestion is welcomed.

thanks
 
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Michael Malis

Quite Involved in Discussions
#2
...and our distributor sends us a complaint regarding a vascular port. There is not much information available on the complaint.

Patient develops a rash, one week after implantation of a vascular port, at the site of the port. Patient was referred to a dematologist. Cause of rash is unknown. Nothing more is reported. Several attempts were conducted to get info....There is no indication of device malfunction or injury reoccuring if device were to malfunction again. I guess seeing a dermatologist would be some sort of intervention. There is so far a single incident

Is this a MDR reportable? How would FDA view this?
In most cases, should the conservative approach of filing a MDR be the answer.
All advice and suggestion is welcomed.
Hi Wes,

Patient developed a rash, cause is unknown. You made several attempts to collect more information (what is not clear from patient or distributor). I would still try to get in touch with the patient and get a product back for evaluation. I also recommend to document your "several attempts" in the complaint file. If you still don't have any additional information/ receive any product back - I would test some retain samples to make sure that product is OK and does not generate any rush.

If every internal test will be acceptable, no MDR will be justifiable because there is no serious injury, no confirmation and because it is a 1st complaint that you can not verify...

Hope this helps,
Mike
 

Qara123

Involved In Discussions
#3
I would file an MDR because there is insufficient information demonstrating that the rash was not caused by the device. The rash is very likely caused by the surgical procedure/device since it occurred at the site of the port. Also, a rash may indicate an allergic reaction to the device that was severe enough to warrant a visit to a dermatologist (i.e. a specialist) but you might want to get an MD's opinion on that.

In the MDR manufacturer's narrative, I would list all steps taken to get more information and state the opinion that the rash was not caused by the device because there had only been one complaint.

Being conservative is the better/safer way to go, IMO. FDA recently won a battle against TMJ implants for not filing MDRs. http://www.mddi-digital.com/mddi/201001#pg26

Q
 

Michael Malis

Quite Involved in Discussions
#4
I would file an MDR because there is insufficient information demonstrating that the rash was not caused by the device. The rash is very likely caused by the surgical procedure/device since it occurred at the site of the port. Also, a rash may indicate an allergic reaction to the device that was severe enough to warrant a visit to a dermatologist (i.e. a specialist) but you might want to get an MD's opinion on that.

In the MDR manufacturer's narrative, I would list all steps taken to get more information and state the opinion that the rash was not caused by the device because there had only been one complaint.

Being conservative is the better/safer way to go, IMO. FDA recently won a battle against TMJ implants for not filing MDRs. http://www.mddi-digital.com/mddi/201001#pg26

Q
:nope::confused:
Skin irratation test on Retain samples will provide sufficient information that the rash WAS or NOT caused by the device!
 

Qara123

Involved In Discussions
#5
I would expect a rash test (or some form of sensitization testing) to have been performed as part of pre-clinical testing and shown the device to be non-irritating.

The device itself may not cause rash. However, a combination of the device and the surgical procedure may have caused it.

Take for example Toyota's nightmare recall. I'm sure if they test the accelerator of my lovely Corolla today, the pedal will not get stuck. But the fact is there's problems in the field and that's what an MDR is for, reporting problems in the field.

Furthermore, why take the risk of not reporting a potentially reportable event, especially if it's just one complaint that is probably not device related.

Q
 
A

arios

#6
The device itself may not cause rash. However, a combination of the device and the surgical procedure may have caused it.
Q
Thanks QARA123

I would add that other factors could be considered, including patient environment, or that a certain sector of a population may be more susceptible than others.

Performing an investigation to get to more conclusive results could require more time, in the time being the clock is still ticking and waiting longer may bring further compliance issues.

Like it was mentioned above and I agree, it is better to be conservative. Reporting an MDR does not mean the manufacturer accepts that the event is related to a device failure, and the MDR template can include verbiage with a similar disclaimer.

Lastly, if a decision is made not to report an event that appears to be reportable then it is better to have involved a professional with the appropriate competence to document a rationale (take a look to the FDA program 7382.845). This could be a Medical doctor, Nurse, Biomedical engineer or other qualified professional recognized by the regs. :2cents:
 

Michael Malis

Quite Involved in Discussions
#7
....I would add that other factors could be considered, including patient environment, or that a certain sector of a population may be more susceptible than others. Performing an investigation to get to more conclusive results could require more time, in the time being the clock is still ticking and waiting longer may bring further compliance issues....it is better to have involved a professional with the appropriate competence to document a rationale (take a look to the FDA program 7382.845). This could be a Medical doctor, Nurse, Biomedical engineer or other qualified professional recognized by the regs. :2cents:
:agree::applause:Great point Amigo,

I am in agreement with you 100%, - you should consider patient environment!
However, regardless of the Reporting, you need to investigate a Root Cause of the problem. Performing skin sensitivity and irratation test on retains will prove that the device itself may not cause this rash!

:frust:Here why I am not in agreement with Qara - "a combination of the device and the surgical procedure may have caused problem". What about the possibility that the procedure (or how it was performed) is the cause of this problem? Why should we close the door on potential doctor/nurse mistake? My point is that if the device is NOT source of Contamination, - it should not be responsible for the surgical procedure or how it was performed!
 
A

arios

#8
This is the GHTF guidance for user errors which did not result in patient's death, serious injury or public health threat:

"Use error related to medical devices, which did not result in death or serious injury or serious public health threat, need not be reported by the manufacturer to the national competent authority. Such events should be handled within the manufacturer’s quality and risk management system, as described in Appendix D Section 6.0. A decision to not report must be justified and documented"

This text was taken from: GHTF/SG2/N54R8:2006 :read: and the link is:
http://www.ghtf.org/documents/sg2/SG2-N54-R8-2006-Proposed.pdf

However before it is decided that the event is not reportable because it could be a potential user error, please first confirm that it is actually a user error and the severity of the event

This brings back again the necessity to have the opinion of qualified personnel to make the call. This same GHTF guidance also mentions:

"The evaluation [talking about use errors] is governed by risk management, usability engineering, design validation, and corrective and preventive action processes"
 
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Michael Malis

Quite Involved in Discussions
#9
...GHTF guidance for user errors..:

"Use error related to medical devices, which did not result in death or serious injury or serious public health threat, need not be reported by the manufacturer to the national competent authority. Such events should be handled within the manufacturer’s quality and risk management system, as described in Appendix D Section 6.0. A decision to not report must be justified and documented"...

This brings back again the necessity to have the opinion of qualified personnel..."
:yes:
Excellent point Amigo, -thanks for GHTF reference.

The key is Risk management and the opinion of qualified personnel. This is why your Medical, Clinical, Quality Engineering and Regulatory people must be involved in this process!
 

Qara123

Involved In Discussions
#10
What about the possibility that the procedure (or how it was performed) is the cause of this problem? Why should we close the door on potential doctor/nurse mistake? My point is that if the device is NOT source of Contamination, - it should not be responsible for the surgical procedure or how it was performed!
I agree that, in all likelihood, the device did not cause the rash. However, it may have somehow contributed to it (Part 803 states "caused or contributed"). The possibility that the procedure and/or medical professional was the cause is valid but remains unverified.

My point is that the manufacturer currently does not possess sufficient information to justify that the device did not cause or contribute to the rash and what you don't know WILL come back and bite you where the sun don't shine.:)

If additional information is available later on, great. But till then, the decision should be made on currently available information.

Q
 
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