Medical Device Malfunction during misuse - Does this need to be reported to the FDA?

C

coilgirl

#1
the event was not the result of a device malfunction but of using the device contrary to its labeled intended use.
it happened in the EU, no medical intervention was necessary, the hospital reported it to the local EU government agency.

1) is this even reportable based on the nature of the event?

2) if it is reportable, is it my obligation to report it to FDA or anyone else based on what's already been reported?

the distributor deemed it not reportable but we are the manufacturer and we get the 510(k) and CE mark it. the distributor is the OEM manufacturer of the equipment our device plugs into.

any insight is appreciated!
 
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pkost

Trusted Information Resource
#2
Re: is this a reportable event?

You haven't really given enough information to determine if the event is reportable, your post raises a number of questions, without specifics it is impossible to say:

you say no medical intervention was necessary - was this out of luck or would it always be the case?

did it cause any harm to the patient? did it extend the duration of the the intervention? If not harm was caused, was that out of luck or would that always be the case?

Also you say that the use was contrary to the labeled use; is that misuse something you could have anticipated? was it a reasonable mistake for the user to make? is it clearly contraindicated? Is that contraindication really clear enough?


Even though the hospital has reported it to the CA or "some body", it is still your responsibility to report as well (if appropriate)

The MEDDEV is a good guidance document which will help you determine if your event is reportable, you can find it here: http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1-rev_6-12-2009_en.pdf
 
C

coilgirl

#3
Re: is this a reportable event?

the patient was burned, certainly a more severe burn would require intervention. the event was reported as a burn after the imaging procedure, without any treatment of the burn, from the pictures, it just looks red, intact tissue, etc.
the device is designed and labeled for knee use, the operator choose to image the patient's thumb, there's nothing I can do to the device or it's labeling to prevent such misuse.
 
M

MIREGMGR

#4
Re: Medical Device Malfunction during misuse - Does this need to be reported to the F

Based on Warning Letters over the past few years, my understanding of the current US FDA standard for reportability is if a doctor was involved in the determination of need for treatment, report.

The FDA MDR system requires the filing of a report for an incident that involved your device but wasn't your fault. The only determining factor is if the device that was involved was yours. You explain your view of the fault situation within the report.
 
Last edited by a moderator:
C

coilgirl

#5
Re: Medical Device Malfunction during misuse - Does this need to be reported to the F

thanks to all, I do understand we have to report regardless of "fault", just seems FDA does not provide much guidance on "serious injury", it seems like when in doubt and in the absence of concrete guidance, it' s easier just to report.
 
A

Arnthor

#6
Re: Medical Device Malfunction during misuse - Does this need to be reported to the F

I was informed by a US consultant that if you are in doubt, it always better to report.

US FDA cannot fault you for over reporting but they can issued a warning letter to your company for under reporting. If you weight the pros and cons, I think it is better to report.
 
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