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Dear all,
I am writing asking for your help in this situation:
An hospital (our customer) filled in an MDR directly to FDA. We remained unaware of this event until FDA sent us some days ago the MDR that the hospital filled in. According to my experience this is normal: if FDA receives an MDR from a hospital notifies the fact to the manufacturer, which needs to evaluate the event and send MDR to FDA if necessary.
But some days later we received another letter from FDA asking to find the root cause of the event, to indicate how many events of this kind we received, and some other investigation activities. This never happened in my experience.
I think this happens when FDA is afraid that the event might be life threatening, but I ask if any of you have ever had a similar experience.
We have 45 days to respond to the letter.
thanks in advance!
I am writing asking for your help in this situation:
An hospital (our customer) filled in an MDR directly to FDA. We remained unaware of this event until FDA sent us some days ago the MDR that the hospital filled in. According to my experience this is normal: if FDA receives an MDR from a hospital notifies the fact to the manufacturer, which needs to evaluate the event and send MDR to FDA if necessary.
But some days later we received another letter from FDA asking to find the root cause of the event, to indicate how many events of this kind we received, and some other investigation activities. This never happened in my experience.
I think this happens when FDA is afraid that the event might be life threatening, but I ask if any of you have ever had a similar experience.
We have 45 days to respond to the letter.
thanks in advance!