Federal law requires the doctors to report an adverse event on a Class III Medica Device - has your doctor reported?
- 10 months ago
Has your doctor or any doctor you see for an adverse event with sculptra report or reported the adverse event to the company (Galderma currently owns Sculptra which is mfg. by Sanofi Aventis) who again by law must then report to the FDA or has or did the doctor directly report the adverse event to the FDA?This is required by law. I have made comment to FDA that there should not be so many 'voluntary' reports for adverse events in the FDA Maude database, they should be coming from doctors, it does not have to be the doctor (ethically they should but that is another subject) who injected you, but Any doctor who you see in regards to sculptra and an adverse event from the product. PLEASE INFORM THE DOCTOR TO REPORT AS IT IS REQUIRED BY FEDERAL LAW. some doctors do not realize it is considered a class III high risk medical device.i am curious of a count if whether you reported to the FDA, or a doctor did on your behalf.