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MedWatch Report from a hospital due to a quality issue

#1
We are a distributor and received a MedWatch report from a hospital due to a quality issue on the device that we distribute. Since we are not the manufacturer, do we just forward the report to the mfg and have them provide the response to FDA? Is there any other step that we need to take as the distributor?

Thanks!
 
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#4
Thank you all for the feedback.
The quality agreement is currently in draft mode and is yet to be finalized. I guess we better make clear in there about MDR responsibilities.

So at this point, all we can do is provide the details to the mfg and have them respond, correct?
 
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