How to Report a Defective Medical Device

Defective medical devices—ranging from pacemakers and joint implants to surgical mesh and insulin pumps—can lead to severe, even life-threatening consequences. Unlike over-the-counter products, medical devices are deeply embedded in patient care. When they fail, the results can include organ damage, infection, revision surgery, permanent disability, or death.

Recognizing what to do in the aftermath is critical—not just for your recovery, but for preventing harm to others. Below is a step-by-step guide on reporting a defective medical device, protecting your rights, and pursuing legal remedies if negligence or manufacturing flaws were involved.

For guidance on related personal injury matters, breaks it down in how to handle a defective product claim.

1. Seek Immediate Medical Attention

The very first step is to protect your health. If you believe a device has malfunctioned or caused unexpected pain, inflammation, infection, or any unusual symptoms:

• Contact your doctor or specialist immediately.
• Visit the emergency room if symptoms are severe or rapidly worsening.
• Describe in detail how the device behaved or failed.

Keep records of:

• Diagnosis and treatment related to the defect
• Medical bills and prescribed medications
• X-rays, MRIs, or other scans used to detect the issue

This documentation becomes crucial when pursuing compensation. The FDA’s Medical Device Reporting (MDR) page offers updated guidelines for patients and healthcare providers alike.

2. Preserve the Device and Related Materials

If it's safe to do so, keep the defective device, any fragments, or removed components in your possession. This allows attorneys, manufacturers, or experts to evaluate it later.

Also preserve:

• Original packaging
• Instruction manuals
• Purchase or implantation receipts
• Medical device implant cards (often given after surgeries)

Important: Do not attempt to alter, repair, or tamper with the device yourself. Doing so could compromise evidence or reduce your chances of a successful claim.

Outlines how proper evidence preservation plays a key role in our process for a personal injury lawsuit.

3. File a Report Through the FDA’s MedWatch Program

MedWatch is the FDA’s safety reporting system for faulty medical devices. This step helps regulators spot device failures, uncover systemic defects, and possibly issue recalls.

To file a MedWatch report:

• Go to the MedWatch Voluntary Reporting Form
• Include key information:
• Device brand and model number
• Date of implantation (if applicable)
• Description of the incident
• Symptoms or injuries experienced

Pro Tip: Include photos, dates, and medical outcomes if available. Clear and thorough reports help the FDA take faster action and improve public safety.

4. Notify the Device Manufacturer and Your Healthcare Provider

Once you've reported the issue to the FDA, notify:

• Your device manufacturer: They may request return of the device for investigation or offer further guidance. Keep all communications.
• Your doctor or surgeon: They need to update your treatment plan and medical records and may also be required to submit reports to the manufacturer and FDA.

Strong communication is key when building a legal case. Learn how transparency between client, doctor, and legal team matters in guide on why communication matters when choosing a law firm.

5. Consult a Personal Injury Attorney

Defective medical device claims fall under product liability law—a complex area that often pits consumers against major corporations. You may have a valid legal claim if the device:

• Was designed or manufactured defectively
• Lacked adequate safety warnings or instructions
• Caused injury despite proper use

An attorney experienced in these cases can:

• Investigate the defect
• Hire medical and engineering experts
• File claims against manufacturers, suppliers, or distributors
• Negotiate a settlement or go to trial if needed

For an example of how these cases unfold, see success story on securing a multi-million dollar settlement for a brain injury victim.

6. Know the Statute of Limitations

Every state has a legal time limit—called the statute of limitations—for filing injury claims. In product liability cases, this is typically 2–4 years from:

• The date of the injury
• OR the date you reasonably discovered the defect (which may come later)

Missing this window could prevent you from pursuing any compensation, no matter how severe your injury.

Learn more in explainer on understanding the statute of limitations for an injury claim.

Why This Matters

When medical devices fail, they don’t just disrupt lives—they can endanger them. By reporting defects and seeking legal help:

• You protect yourself and your family from further harm
• You help prevent future injuries to other patients
• You can recover financial damages for your losses

Whether it’s a faulty hip implant, a pacemaker malfunction, or a surgical mesh failure, the steps you take can make a lasting difference—for your health and for public safety.

Key Takeaways

• Act quickly: Your health and legal rights depend on timely action.
• Document everything: Medical records, device info, receipts, and photos.
• Report to the FDA: Use the MedWatch form to create an official report.
• Talk to a lawyer: Product liability attorneys understand how to navigate these cases and maximize your chance for recovery.