Get the free Medical device adverse incident report form - mhra gov

This form is designed for the public to report problems encountered with medical devices to the MHRA, enabling them to investigate and prevent future incidents.

How to fill out medical device adverse incident

How to fill out Medical device adverse incident report form

1. Obtain the Medical Device Adverse Incident Report form from the relevant regulatory body or organization's website.
2. Fill in the details of the reporter, including name, contact information, and relationship to the incident.
3. Provide specific information about the medical device involved, including the device name, model number, and serial number.
4. Describe the adverse incident clearly and concisely, including what happened, date and time of the incident, and any injuries or outcomes associated with it.
5. Indicate if the device was in use at the time of the incident and describe its condition prior to the adverse event.
6. Include any actions taken after the incident, including whether the device was removed from use or reported to the manufacturer.
7. Review the completed form for accuracy and completeness before submission.
8. Submit the form as directed, either online, via email, or by postal service, and keep a copy for your records.

Who needs Medical device adverse incident report form?

1. Healthcare professionals who encounter adverse events with medical devices.
2. Manufacturers of medical devices for defect tracking and improvement.
3. Regulatory bodies for monitoring device safety and effectiveness.
4. Patients or consumers experiencing adverse incidents to ensure they are documented and addressed.

For pdfFiller’s FAQs

What is Medical device adverse incident report form?

The Medical device adverse incident report form is a document used to report any adverse events or incidents related to the use of a medical device, which can include serious injuries, deaths, or failures of the device that could affect patient health.

Who is required to file Medical device adverse incident report form?

Manufacturers, importers, and healthcare professionals who witness adverse events involving medical devices are typically required to file the Medical device adverse incident report form.

How to fill out Medical device adverse incident report form?

To fill out the Medical device adverse incident report form, one should provide detailed information about the incident, including the device involved, the nature of the incident, patient information, and any actions taken following the incident.

What is the purpose of Medical device adverse incident report form?

The purpose of the Medical device adverse incident report form is to enhance patient safety by collecting data on adverse events, allowing regulatory bodies to identify trends, assess risks, and implement actions to prevent future incidents.

What information must be reported on Medical device adverse incident report form?

The information that must be reported includes the device name and model, description of the adverse event, patient demographics, date and location of the incident, context of use, and any corrective actions taken.