Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study
Everhart A, Karaca-Mandic P, Redberg R, Ross J, Dhruva S. Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study. The BMJ 2025, 388: e081518. PMID: 40081838, PMCID: PMC11898541, DOI: 10.1136/bmj-2024-081518.Peer-Reviewed Original ResearchConceptsAdverse event reportingPatient safety concernsLate adverse eventsAdverse eventsEvent reportingCross sectional studyDrug AdministrationProportion of reportsMedical device adverse eventsEarly detectionSectional studyDevice adverse eventsInitial adverse eventsUS FoodMedical device manufacturersUser Facility Device ExperienceSurveillance toolManufacturer reportsFDA MAUDE databaseDevice experienceLatest reportsMAUDE database
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