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    Reporter’s occupation and source of adverse device event reports contained in the FDA’s MAUDE database by Kavanagh KT, Brown RE Jr, Kraman SS, Calderon LE, Kavanagh SP

    Published 2019-07-01
    “…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. …”
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