Medical Device Reporting and Does it Actually Happen

Medical Device Reporting and Does it Actually Happen

In most instances, manufacturers of medical devices have the patient’s best interest in mind because the devices are designed to help, improve and save lives. However, there are cases in which testing is not thorough enough, and adverse events happen from faulty medical devices. Devices such as hip implants, duodenoscopes and many more that are meant to help patients can cause more damage and pain in certain cases. Every year there are hundreds of patients that fall victim to adverse events caused by faulty medical devices.

In the event that a medical device is faulty, the patient may be unable to return to work, suffer from life-altering complications, live with debilitating pain or even die. When this happens, the obvious question that comes to mind is, “Did the company produce a faulty medical device that led to this event?” When it comes to faulty medical devices, the U.S. Food and Drug Administration has requirements and guidelines that device user facilities must follow in any event that a device may have been faulty or malfunctioned. Examples of device user facilities are hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities and outpatient treatment facilities. When a medical device-related injury or death occurs, the device user facility is required by federal law to report it to the FDA and the manufacturer of the device. For serious injuries and deaths, the medical device reporting (MDR) is required to be submitted within 10 work days of the event.

Medical device reporting (MDR) should include if there was an injury, the extent of the injury, description of the device problems, medical procedures for the device being used, follow-up medical procedures as a result, name of the device manufacturer, ID numbers of the medical device and what was done to solve the problem. All of this information can either be reported online and submitted on the eMDR website or submitted on FDA Form 3500A. In addition to medical device reporting of an adverse event, device user facilities are also required by federal law to submit semi-annual reports on January 1 and July 1, each year.

These laws and requirements that are put in place by the FDA are great, only if the device user facilities actually follow them. The main purpose of medical device reporting (MDR) is to identify potentially defective medical devices early and prevent any further potential injuries or deaths that may result from the use of the faulty device. However, the reporting may not be occurring the way that it is supposed to after recent reports and inspections have come to light. Recently, according to the FDA’s inspection of 17 hospitals, evidence was found that the hospitals were largely underreporting the number of adverse events related to faulty medical devices. The investigations began after serious concerns were raised over two medical devices that have caused a number of serious injuries and even some deaths. Safety issues had occurred involving either duodenoscopes or power morcellators, a surgical tool used in hysterectomies. Morcellators are used to cut up benign growths called fibroids, but the FDA has warned about the device spreading cancerous tissue in the abdomen and pelvis.

The FDA believes that the 17 hospitals are not the only ones underreporting events but is most likely happening in hospitals around the country. The cause of this can be attributed to inadequate staff training on how to report in accordance with FDA regulations and not all hospitals having the processes, procedures, and means to report such devices and events.

While there are laws in place to help improve safety, they are not always followed as required. If you believe that you or someone you know is the victim of an adverse event related to a faulty medical device, it is important that you know your rights and that you fight for compensation for your pain and suffering.

Contact the experienced personal injury attorneys at Blaut Weiss Law Group at to receive a free consultation.