C
the event was not the result of a device malfunction but of using the device contrary to its labeled intended use.
it happened in the EU, no medical intervention was necessary, the hospital reported it to the local EU government agency.
1) is this even reportable based on the nature of the event?
2) if it is reportable, is it my obligation to report it to FDA or anyone else based on what's already been reported?
the distributor deemed it not reportable but we are the manufacturer and we get the 510(k) and CE mark it. the distributor is the OEM manufacturer of the equipment our device plugs into.
any insight is appreciated!
it happened in the EU, no medical intervention was necessary, the hospital reported it to the local EU government agency.
1) is this even reportable based on the nature of the event?
2) if it is reportable, is it my obligation to report it to FDA or anyone else based on what's already been reported?
the distributor deemed it not reportable but we are the manufacturer and we get the 510(k) and CE mark it. the distributor is the OEM manufacturer of the equipment our device plugs into.
any insight is appreciated!