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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?
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?