Medical Device Malfunction Reports Found in Hidden FDA Database and Kept From Public Eye

Medical device manufacturers are responsible for ensuring their products are safe for public use, and that the public is informed of potential malfunctions. When manufacturers fail to meet these standards, serious physical harm and even death can occur. Here, the medical device attorneys at Sullivan Papain Block McManus Coffinas & Cannavo, P.C. provide an overview of the hidden FDA medical database that numerous medical device companies have used for years to keep malfunction reports under wraps. 

What is The Hidden FDA Database? 

MAUDE is a highly visible and transparent database for medical device malfunctions and is used frequently as a resource for the medical community and patients. However, recently a hidden database came to light, which device makers had been using for the past 20 years to report harm caused by their products.  In June of 2019, the FDA commissioner released 5.7 million records previously inaccessible to the public that detailed malfunctions and harm caused by medical devices. 

These records included numerous Class I recalls, meaning the devices in question had the potential to cause immediate and serious harm or even death. Not only were these documents inaccessible to the public, they were hidden from doctors, hospitals and other medical entities as well—even respective FDA officials may have been unaware of the hidden database. With little to no knowledge of the implications of these devices, many medical professionals could have risked their careers and the safety of their patients. The alternative summary report that companies used to furtively report their product malfunctions have accounted for 40% of device malfunction reports for the past two decades, all of which have just been released this year. 

How Have These Reports Harmed Patients? 

The now-public report from this hidden database has revealed the hazardous nature of many of these failed devices, and the exponential risk posed to patients whom they have been used on. For example, 44% of the malfunctioned devices in the hidden report were implanted into patients, while only 10% of devices from the public MAUDE database were implanted. Devices such as pelvic mesh, surgical staplers, dental implants and pacemaker leads were some of the approximately 100 devices found in these reports. Not only does this lack of transparency risk physical harm to patients, but it can induce mental and emotional anguish as well. Affected patients can face physical pain and complications that, if left unnoticed, can impact their wellbeing and ability to perform everyday tasks.

How the Medical Device Attorneys at Sullivan Papain Block McManus Coffinas & Cannavo, P.C. Can Help You 

Medical device malfunction can often be the basis for a product liability lawsuit.  Previously hidden reports have prevented patients and medical professionals from determining the potential risks of a multitude of devices. If you have suffered physical injury after a surgical procedure in which a medical device was implanted or used to carry out the procedure, you may be a victim of a medical device defect.  To discuss your legal options with a dedicated attorney at Sullivan Papain Block McManus Coffinas & Cannavo, P.C., contact our New York office today.