Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database.
other · Level V
Where this comes from
- Record sourced from PubMed, PMID 31589249.
- Also identified by DOI 10.1001/jamainternmed.2019.4030 and PMC identifier 6784806.
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Abstract
This database study assesses the misclassification of death reports for 2 medical devices within the US Food and Drug Administration’s Manufacturer and User Facility Device Experience database.
Medical subject headings
- Adverse Drug Reaction Reporting Systems
- Drug-Related Side Effects and Adverse Reactions
- Product Surveillance, Postmarketing
- United States Food and Drug Administration