Do product manufacturers have access to the reporting institution and the reporters names after a report is filed with MedSun?
A. Yes, MedSun will forward a copy of the report to the manufacturer that produces the particular device or devices mentioned. This report will include institutional identifiers as required under SMDA. This way, the manufacturers will be able to follow-up concerning reported events. This is the same procedure that is followed today when a facility submits a hard-copy MedWatch 3500A form.
Related Questions
- If we report to MedSun, do we still have to report adverse medical device events to FDA and manufacturers on MedWatch Form 3500A?
- Do product manufacturers have access to the reporting institution and the reporters names after a report is filed with MedSun?
- Why do flooring manufacturers recommend not smoothing true expansion joints with any type of underlayment product?
