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Get Adverse Drug Reaction And Product Quality Problem Report Form - Sgfp Dfdy Co
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How to fill out the Adverse Drug Reaction And Product Quality Problem Report Form - Sgfp Dfdy Co online
This guide provides clear instructions on how to effectively complete the Adverse Drug Reaction And Product Quality Problem Report Form - Sgfp Dfdy Co online. By following these steps, you can ensure that you accurately report any adverse drug reactions or product quality issues to the appropriate authorities.
Follow the steps to complete the form efficiently.
- Click ‘Get Form’ button to access the online form.
- Begin by entering the patient information. Fill in the name (or initials), select the sex of the patient, and provide the age, date of birth, weight, and height.
- In the adverse reaction/product quality problem section, specify whether you are reporting an adverse reaction, a product quality problem, or both. Record the date and time when the reaction or problem began.
- Describe the reaction or problem in detail, including any relevant test results or lab data along with their respective dates.
- List all concomitant medications, vaccines, or devices the patient has used, including the trade name, batch number, daily dosage, route, dates started and stopped, and reasons for use. Mark the suspected product with an asterisk.
- Indicate the outcome of the adverse reaction by checking all applicable boxes, including options such as death, life-threatening, disability, and hospitalization.
- Provide treatment details for the reaction and describe any sequelae if applicable.
- In the comments section, include any relevant medical history, allergies, and previous exposures that are pertinent to the case.
- For product quality problems, detail the trade name, batch number, and registration number, along with availability for evaluation.
- Complete the reporting section by providing the name, qualifications, address, and contact information of the reporting individual. Ensure you also sign and date the form.
- Review all entries for accuracy, then save your changes. You can download, print, or share the form as necessary.
Start completing the Adverse Drug Reaction And Product Quality Problem Report Form - Sgfp Dfdy Co online now to help improve drug safety.
Call FDA at 1-800-FDA-1088 to report by telephone. Reporting Form FDA 3500 commonly used by health professionals.
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