Cause Cancer or not? Claims cancer came back after using a medical device

L

luloo117117

#1
A common question:

If a customer reported that his/her cancer came back after using your medical device. We checked the controindications in our user manual and predicate devices and clinical bibliography, can not find any clue to cancer.

We also never say it can be used for cancer treatement. The patient had the cancer before, and cancer can come back for any reason.

What we should do if we received this feedback?
 
Elsmar Forum Sponsor
#2
Re: Cause Cancer or not?

I am not an expert on cancer, and I have no idea what your device is, but for what its worth.

Cancer is a very peculiar thing. We know that certain behaviors and certain products can be linked to cancer. However not everyone who engages in that behavior, or uses that product will get cancer, and there are some that get cancer who don’t engage in risk activities and products. It would be very hard for me to believe that the use of your device caused a certain person’s cancer.

However, I don’t think you should just dismiss the comment. You might want to do a little digging and see if this is isolated, or if there is evidence that others are also experiencing the same effects.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
I find it hard to believe a medical device would cause a recurrence of cancer. I'd put it in the hands of the company lawyer immediately. People will sue or otherwise try to get money any way they can from anyone or any company they can whether there is fault or not.
 
L

luloo117117

#4
Our devices are used for several thunsands times by doctors in the past 3 years. Nobody told us it will triggered the cancer back or caused cancer after using our laser.

The customer did not provide any evidence to say it is our device's problem, just imagined and raised a question to us: does your device cause it back?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
...does your device cause it back?
I have never heard of a laser causing cancer or a recurrence of cancer, but as has been posted, your company lawyer should be notified. If I was to answer I would tell the person "Not that we are aware of."
 
S

somerqc

#7
Call the lawyer - this is something that should be handled with kid gloves. If they are fishing, it is best to be protected.

It reminds me of the parents of a child at our daycare that said that "Freezzee's" (frozen flavoured/coloured sugar water) were giving her child colds. Looking for some reason why her child kept getting colds. (Nope - couldn't be the fact that they are there with ~150 other kids that spread germs like dandelions spread seeds in the spring)
 
L

luloo117117

#8
Many thanks to all.

Should we call lawyer outside or QA (regulatory affairs) guy inside company?

I am not sure what's the difference between lawyer and QA in this case.
 
M

MIREGMGR

#9
Aside from the various suggestions regarding notification of your corporate law firm as to the complaint, you also should handle it via your post market surveillance/complaint handling procedure per your FDA/MDD quality systems. As has been discussed here on prior occasions, the FDA has specific complaint reporting requirements, for instance.
 
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