Have you tried using the FDA Reporting Resource for Clinicians from Epocrates? Here's what it offers:
Whenever you think a medical product may be associated with a serious event (seizure, bronchospasm, GI bleed, hospitalization, life-threatening illness, disability, congenital anomaly, etc.) You need not be sure about causality; if you suspect the product is associated with a serious event, FDA is interested.
Reporting is easier than you think. Although the form asks for many details, the only required info is the product and a description of the problem.
Your report might be the vital action that prompts a change in drug design, identifies unsuspected drug toxicity, or leads to safer use for patients.
Anyone can report a serious adverse event that may be associated with a medical product or device.
It takes only minutes. There are 4 ways to report: secure online forms available; one-page fax or mail form, or phone 1-800-FDA-1088.
FDA has created a safe environment for sharing patient data for public health surveillance. HIPAA allows for reporting of adverse events to FDA without patient authorization. No follow-up from FDA or manufacturers is required; reporting is not an admission of fault.
Learn more about the Epocrates FDA Reporting Resource for Clinicians here.
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