Get Adverse Event Report Form

Filling out the Adverse Event Report Form online is a crucial step in reporting incidents related to medical devices. This guide will walk you through each section of the form to ensure that you can complete it effectively and accurately.

Follow the steps to successfully complete your report

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Begin by filling in the patient details section. Provide information such as the patient's hospital, sex, date of birth or age at the time of the event, and weight in kilograms.
3. Next, proceed to the event details section. Describe the event in detail including the reason for the event. Tick the appropriate category such as electrical, mechanical, electronic, or other related reasons.
4. Indicate the severity of the event. Choose from options such as death, life-threatening, required intervention, hospitalization, disability, or other impairments, and specify as necessary.
5. Provide the date of the event and the location where it occurred, such as outpatient department (OPD) or inpatient department (IPD).
6. Specify the device category. Choose from options like therapeutic, implantable, diagnostics, single-use device, reusable device, or other categories.
7. Fill in the details related to device maintenance, including the date of last preventive maintenance or calibration.
8. In the device details section, provide information regarding the device manufacturer, brand name, model number, serial number, batch number, and installation date if applicable.
9. Indicate whether other medical devices were in use at the time of the incident and provide the accompanying details if applicable.
10. Complete the form by providing your contact information, including your name, title, organization, and relevant regulatory details.
11. Once you have filled in all sections of the form, review your entries for accuracy. You can save changes to the form, download it, print it, or share it if needed.

Complete your Adverse Event Report Form online today to ensure timely and effective reporting.