When FDA receives an MDR from user and sends a letter to the manufacturer

L

Lu288

#1
#1
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!
 
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B

boyan

#3
#3
Lu288 said:
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!
Click to expand...
This is very common in FDA regulated industry. It's clear that your device has malfunctioned and you have to get the report from the hospital about the incident (if you give us more info on the incident we might be able to give you better direction), show and document good faith obtaining information of the incident and patient info (again, not sure if user height/weight matters, condition etc.), evaluate the risk, perform and determine root cause of the incident and take corrective action.
 
J

Julie O

#4
#4
I have only worked "around" MDRs, never with them, but I've not heard of a second letter before. This doesn't mean they are extremely rare, but if they were standard practice for every report filed by a healthcare provider, I'd be a little surprised I'd never heard of one even being mentioned by the folks who do handle MDRs. In that case, I'm inclined to agree with you, that the FDA found this particular event to be of more than usual interest, although I wouldn't go so far as to conclude they think it's life-threatening. It might just be something that is on their radar right now. For example, I wouldn't be surprised if they had queried all reports for metal-on-metal implants for a period of time, without thinking they were life-threatening.
 
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