Patient Safety First: How to Report a Defective Medical Device

Medical devices, ranging from pacemakers and insulin pumps to surgical mesh and joint implants, are meant to improve and protect lives.

But when these products fail, the results can be devastating. 

A defective medical device can cause injuries, complications, or even death. That’s why it’s crucial for patients and caregivers to know how to report problems to the U.S. Food and Drug Administration (FDA) or other regulatory bodies. Doing so not only helps protect your health but also prevents similar harm to others.

At Morgan & Morgan, we believe patient safety should always come first. Here’s a practical guide to reporting a defective medical device.

Why Should I Report a Medical Device Defect?

Reporting medical device defects isn’t just about your personal situation; it’s about public health. Every report helps regulators identify patterns and take action, whether that means issuing safety alerts, mandating recalls, or requiring manufacturers to fix design flaws.

By filing a report, you document your own experience and injuries, while contributing to nationwide safety data. By doing this, you help protect future patients from harm and support accountability for manufacturers.

Most importantly, this creates an official record of the issue, and should you suffer harm due to a medical device defect and choose to file a personal injury claim, this report serves as important evidence to support your claim.

Step 1: Gather the Necessary Information

Before making a report, collect as much detail as possible. The FDA relies on specific, accurate data to investigate. Information you should gather includes:

• Device details: Brand name, model, lot or serial number, and manufacturer.
• Date of use or implantation: When and where you received the device.
• Problem description: What exactly went wrong? Did the device malfunction, break, or cause unexpected side effects?
• Injury details: Any medical complications, hospital visits, or long-term health effects.
• Medical documentation: Reports from doctors, hospitals, or labs that confirm the problem.
  
   

Step 2: Submit a Report to the FDA

Patients and caregivers can report defective devices through MedWatch, the FDA’s reporting program for safety issues. Here’s how:

1. Online: Visit the FDA MedWatch website and fill out Form FDA 3500B (designed for consumers and patients).
2. By mail or fax: Download and complete the form, then mail or fax it to the FDA.
3. By phone: Call 1-800-FDA-1088 to request a reporting form.

When submitting, include all supporting documents, such as medical records or photos of the device, if available.

Step 3: Report to Your Healthcare Provider

Always inform your doctor or surgeon about the issue. They may file a report directly with the FDA and notify the device manufacturer. This also ensures your health is monitored closely, especially if the defect poses ongoing risks.

Step 4: Report to State or Local Agencies

Some states have their own health departments or consumer protection agencies that collect device-related complaints. Reporting locally can help broaden the response and keep regulators informed at all levels.

Step 5: Contact a Defective Medical Device Attorney

Filing a report with the FDA is about protecting public health, but it does not provide you with compensation for injuries or medical expenses. If you’ve been harmed by a defective medical device, you may be entitled to recover damages for:

• Medical bills and rehabilitation costs
• Lost income or reduced earning capacity
• Pain and suffering
• Wrongful death in cases involving a loved one
  
   

Morgan & Morgan has a dedicated team of product liability attorneys who have fought and won cases against some of the world’s largest device manufacturers. We understand how devastating it is when a device you trust ends up causing harm, and we are here to hold negligent companies accountable.

Protecting Patients, Holding Manufacturers Accountable

Medical device manufacturers have a legal responsibility to design, test, and market safe products. Unfortunately, profit motives sometimes overshadow patient safety, and defective devices reach the market. When that happens, it’s up to patients, healthcare providers, regulators, and attorneys to shine a light on the problem. 

If you or a loved one has been injured by a defective medical device, don’t wait. Report the problem to the FDA to protect others, and contact Morgan & Morgan to explore your legal options.

At Morgan & Morgan, we believe patient safety comes first. If you’ve suffered because of a defective medical device, we may be able to help you pursue justice and compensation. Contact us today for a free, no-obligation case evaluation.