2025
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
2023
Adverse Events Associated With Tracheostomy: A MAUDE Database Analysis
Narwani V, Dacey S, Lerner M. Adverse Events Associated With Tracheostomy: A MAUDE Database Analysis. Otolaryngology 2023, 170: 391-395. PMID: 37622490, DOI: 10.1002/ohn.501.Peer-Reviewed Original ResearchAdverse eventsPercutaneous tracheostomyMAUDE databasePatient-related adverse eventsRetrospective cross-sectional studyDevice-related adverse eventsDevice malfunctionMAUDE Database AnalysisTracheostomy tube obstructionPatient-related factorsRare adverse eventsUser Facility Device Experience (MAUDE) databaseCross-sectional studyBalloon malfunctionDevice-related failuresTracheostomy complicationsTube obstructionOpen tracheostomyCase reportDevice complicationsCuff deflationTracheostomyLine malfunctionPatient injuryFDA MAUDE database
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