---
title: COFEPRIS Medical Device Adverse Event Report Form Template | Paperform
description: Official COFEPRIS adverse event report form for Mexican healthcare facilities. Report medical device incidents, patient outcomes, and device identification with automatic manufacturer notification and regulatory compliance tracking.
url: "https://paperform.co/templates/cofepris-medical-device-adverse-event-report"
type: static
generatedAt: "2026-03-31T00:47:55.465Z"
---

[← Back to free form templates](/templates/)    ![COFEPRIS Medical Device Adverse Event Report](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/cofepris-medical-device-adverse-event-report.png)
    [Preview](https://_preview.paperform.co/ai-template/cofepris-medical-device-adverse-event-report) [Use this template for free](/create?ai-template=cofepris-medical-device-adverse-event-report)    [Healthcare & Medical Forms](/templates/category/healthcare/)[Legal & Compliance Forms](/templates/category/legal/)[Industry-Specific Forms](/templates/category/industry-specific/) [Healthcare](/templates/industry/healthcare/)[Legal](/templates/industry/legal/)[Medical Devices](/templates/industry/medical-devices/) [Physician](/templates/role/physician/)[Nurse](/templates/role/nurse/)[Healthcare Administrator](/templates/role/healthcare-admin/)[Compliance Officer](/templates/role/compliance-officer/)[Quality Manager](/templates/role/quality-manager/)     About this free form template
### COFEPRIS Medical Device Adverse Event Report Form

This **COFEPRIS Medical Device Adverse Event Report Form** is designed to help healthcare facilities, medical professionals, and manufacturers in Mexico efficiently report adverse events involving medical devices to the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).

Under Mexican regulatory requirements, any serious adverse event or malfunction of a medical device must be reported to COFEPRIS to ensure patient safety and maintain regulatory compliance. This form streamlines the reporting process by capturing all essential information including incident descriptions, patient outcomes, device identification, and manufacturer notification details in one comprehensive submission.

#### Who should use this form?

This template is ideal for:

 - **Healthcare facilities** and hospitals managing medical device safety programs
 - **Medical professionals** who encounter device-related adverse events
 - **Medical device manufacturers** and distributors operating in Mexico
 - **Quality assurance teams** responsible for regulatory compliance
 - **Clinical risk managers** overseeing patient safety initiatives

#### Key features of this form

The form captures critical information required by COFEPRIS regulations, including detailed incident descriptions, patient impact assessment, complete device identification (including registration numbers and batch details), manufacturer information, and corrective actions taken. The structured format ensures consistent reporting and helps maintain compliance with NOM-240-SSA1-2012 and other relevant Mexican health regulations.

With Paperform's conditional logic, the form adapts based on event severity and patient outcomes, ensuring appropriate follow-up information is collected. Integration capabilities allow you to automatically route urgent reports to regulatory affairs teams, sync data with quality management systems, and maintain comprehensive audit trails.

For organizations managing multiple facilities or device portfolios, [Stepper](https://stepper.io) can automate the entire post-submission workflow—triggering manufacturer notifications, creating investigation tasks, generating timeline reports for COFEPRIS submission, and keeping all stakeholders informed throughout the resolution process.

This professional, compliant form helps Mexican healthcare organizations meet their regulatory obligations while protecting patient safety and maintaining transparent communication with COFEPRIS authorities.
       Built for growing businesses, trusted by bigger ones.   Trusted by 500K+ business owners and creators, and hundreds of millions of respondents.     ![Capterra - 4.8 out of 5](/images/capterra-st.jpg)
 ![Trustpilot - 4.8 out of 5](/images/trustpilot-st.jpg)
 ![G2 - 4.8 out of 5](/images/g2-st.jpg)
  [Try Paperform free now](/register)
## More templates like this
  [![Denmark Medical Device Adverse Event Report](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/denmark-medical-device-adverse-event-report.png)

### Denmark Medical Device Adverse Event Report

A comprehensive adverse event reporting form for medical devices in Denmark, designed to capture patient CPR details, device information, and incident circumstances in compliance with Danish regulatory requirements.](/templates/denmark-medical-device-adverse-event-report/)
[![Irish Medical Device Vigilance Incident Report Form](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/irish-medical-device-vigilance-incident-report-form.png)

### Irish Medical Device Vigilance Incident Report Form

Report serious adverse events and medical device incidents to the HPRA in compliance with Irish and EU vigilance requirements. Streamline your regulatory reporting workflow.](/templates/irish-medical-device-vigilance-incident-report-form/)
[![Anonymous Organ Procurement Protocol Deviation Report](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/anonymous-organ-procurement-protocol-deviation-report.png)

### Anonymous Organ Procurement Protocol Deviation Report

A confidential reporting form for documenting organ procurement protocol deviations, UNOS notifications, and transplant safety concerns to ensure patient safety and regulatory compliance.](/templates/anonymous-organ-procurement-protocol-deviation-report/)
[![Australian Controlled Substance Authority Application](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/australian-controlled-substance-authority-application.png)

### Australian Controlled Substance Authority Application

Apply for authority to prescribe, supply or administer Schedule 8 or Schedule 4 Appendix D controlled substances in Australia. Streamline TGA compliance with a professional, digital application form.](/templates/australian-controlled-substance-authority-application/)
[![Australian Therapeutic Goods Advertising Complaint Form](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/australian-therapeutic-goods-advertising-complaint-form.png)

### Australian Therapeutic Goods Advertising Complaint Form

Lodge a formal complaint about therapeutic goods advertising to the TGA. Report misleading claims, non-compliant advertisements, and regulatory breaches with supporting evidence.](/templates/australian-therapeutic-goods-advertising-complaint-form/)
[![Clinical Research Adverse Event Escalation Form](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/clinical-research-adverse-event-escalation-form.png)

### Clinical Research Adverse Event Escalation Form

A comprehensive form for clinical research sites to escalate adverse events, document IRB notifications, sponsor reporting, and FDA safety reporting triggers with built-in compliance workflows.](/templates/clinical-research-adverse-event-escalation-form/)
[![Controlled Substance Prescription Monitoring Program Records Request](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/controlled-substance-prescription-monitoring-program-records-request.png)

### Controlled Substance Prescription Monitoring Program Records Request

Request prescription monitoring program records for controlled substances with secure prescriber verification, patient details, and state PMP coordination.](/templates/controlled-substance-prescription-monitoring-program-records-request/)
[![Egypt Clinical Laboratory License Application](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/egypt-clinical-laboratory-license-application.png)

### Egypt Clinical Laboratory License Application

A comprehensive application form for obtaining a clinical laboratory license in Egypt, covering accreditation standards, quality control procedures, and pathologist credentials required by Egyptian health authorities.](/templates/egypt-clinical-laboratory-license-application/)
[![FDA Adverse Event Reporting Form for Medical Device Manufacturers](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/fda-adverse-event-reporting-form-for-medical-device-manufacturers.png)

### FDA Adverse Event Reporting Form for Medical Device Manufacturers

Streamlined FDA adverse event reporting form for medical device manufacturers to document device-related incidents, patient outcomes, and maintain regulatory compliance with timeline tracking.](/templates/fda-adverse-event-reporting-form-for-medical-device-manufacturers/)
[![FDA Medical Device Adverse Event Report (MDR)](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/fda-medical-device-adverse-event-report-mdr.png)

### FDA Medical Device Adverse Event Report (MDR)

Comprehensive FDA medical device reporting form for documenting adverse events, device information, patient outcomes, and manufacturer evaluation in compliance with MDR requirements.](/templates/fda-medical-device-adverse-event-report-mdr/)
[![Finnish Radiation Safety License Application for Medical Imaging Equipment](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/finnish-radiation-safety-license-application-for-medical-imaging-equipment.png)

### Finnish Radiation Safety License Application for Medical Imaging Equipment

Official application form for obtaining a radiation safety license for medical imaging equipment in Finland. Compliant with STUK (Radiation and Nuclear Safety Authority) regulations.](/templates/finnish-radiation-safety-license-application-for-medical-imaging-equipment/)
[![Intensive Outpatient Program Insurance Fraud Confidential Report](https://img.paperform.co/fetch/f_webp/https://d3gw2uv1ch7vdq.cloudfront.net/content/form_templates/assets/intensive-outpatient-program-insurance-fraud-confidential-report.png)

### Intensive Outpatient Program Insurance Fraud Confidential Report

Confidential reporting form for suspected insurance fraud or improper billing practices in intensive outpatient programs, with level of care assessment and utilization review documentation.](/templates/intensive-outpatient-program-insurance-fraud-confidential-report/)