Reporter’s occupation and source of adverse device event reports contained in the FDA’s MAUDE database

Abstract

Kevin T Kavanagh,1 Raeford E Brown Jr,2 Steve S Kraman,3 Lindsay E Calderon,4 Sean P Kavanagh51Health Watch USA, Somerset, KY, USA; 2Department of Anesthesiology, University of Kentucky Medical Center/Kentucky Children’s Hospital, Lexington, KY, USA; 3Department of Internal Medicine, University of Kentucky College of Medicine, Health Watch USA, Lexington, KY, USA; 4Department of Biological Sciences, Eastern Kentucky University, Health Watch USA, Lexingtion, KY, USA; 5Health Watch USA, Solon, OH, USAIntroduction: A review of the medical device adverse events submitted to the United States Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was undertaken to determine the major sources of the information.Methods: The reporter’s occupation and source of the medical device report were determined for acquisition dates Jan 1, 1997 to Dec 31, 2018. A total of 7,766,737 adverse event records were analyzed.Results: 96.6% of reports originated with the manufacturer. Patients (patients/family/friend) were the most frequent submitter of reports directly to the FDA, almost five times as often as physicians. Nurses submitted reports directly to the FDA 2.77 times as often as physicians. Only 0.49% of physician reports were submitted directly to the FDA, representing 0.09% of total MAUDE reports.Conclusion: Increasing physician reporting directly to the FDA and MAUDE through the MedWatch reporting system is an imperative. Incorporating information from the perspective of the physician has the potential of increasing the quality of the data and improving the reliability of post-market surveillance.Keywords: FDA, MAUDE, reporter, occupation, medical device, adverse events

Keywords

• FDA
• MAUDE
• Reporter
• Occupation
• Medical Device
• Adverse Events