Defective medical devices and reporting to the FDA

Advancements in technology have proven to be very resourceful in society. While they hold many benefits, when a product does not function properly because of a defect, this could cause significant harm to the consumer. With regards to medical devices, a patient is under the impression that the device placed inside of their body or used for medical purposes was properly made and functions as intended. Thus, when a defective medical device causes harm, this is not only a shocking event but also one that could significantly impact the health and life of the patient.

The U.S. Food and Drug Administration receives hundreds of thousands of reports each year regarding suspected deaths, injuries and malfunctions associated with a medical device. This type of reporting not only helps monitor device performance, but it also assists with the detection of safety issues related to the product. When a manufacturer, device user facility or an importer suspects defects, they are required to file a report them to the FDA.

Mandatory reporting is required when a medical device may have caused or contributed to a death or serious injury. A device user facility, such as a hospital, is required to report to both the manufacturer, if known, and to the FDA. Although it is not mandatory, the FDA urges health care professionals, patients, caregivers and consumers to file a voluntary report, detailing to serious adverse events that may be associated with a certain medical device.

Suffering harm because of a defective medical device is an unexpected event, as an individual is utilizing such a device to aid or benefit their health. Reports of defects and recalling a defective medical device helps improve patient safety. Thus, if a manufacturer, device user facilities and importers fail to submit these required reports, this could give rise to additional harm caused by a defective product.

In cases of defective medical devices, one may be inclined to take action against the medical professional responsible for his or her usage of the device. While it could be a matter of medical malpractice, when a medical device is defective and caused harm, this is likely a products liability matter. This legal action could help place liability on the party or parties accountable for the defects, helping the injured party secure compensation for losses and damages, such as medical bills, pain and suffering, rehabilitation, lost wages and other losses suffered.