Get Hhs Form Fda-3500 2022-2025

The HHS Form FDA-3500 is essential for reporting adverse events, product problems, and medication errors related to drugs and medical devices. This guide provides a clear, step-by-step process for users to complete the form online.

Follow the steps to complete the HHS Form FDA-3500 online efficiently.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Begin by providing patient information in Section A. Fill in the patient identifier and select the appropriate options for sex, age, gender, weight, ethnicity, and race.
3. Move to Section B. Report any adverse events or product problems. Indicate the type of report and select the outcomes attributed to the event.
4. Fill in the date of the event and date of this report. Describe the event, problem, or error in detail, ensuring you provide as much context as possible.
5. Proceed to Section C. Indicate whether the product is available for evaluation and whether you have a picture to include.
6. In Section D, provide information about the suspect products involved. Fill out the necessary details including product name, strength, manufacturer, dosage, and treatment dates.
7. If applicable, complete Section E for any suspect medical devices, detailing the brand name, model, manufacturer, and other relevant device information.
8. Section F asks for details about other medical products that the patient has used. List any concomitant medications and their therapy dates.
9. Finally, complete Section G with the reporter’s contact information and select if you wish to remain anonymous. Ensure all sections are filled accurately.
10. Review your form for completeness and accuracy. Once satisfied, save changes, download, print, or share the completed form as needed.

Encourage completion of the HHS Form FDA-3500 online to ensure safe reporting of health-related events.