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Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death

IMPORTANCE: In the US, most postmarket medical device safety data are obtained through adverse event reports that are submitted to the US Food and Drug Administration (FDA)’s Manufacturer and User Facility Device Experience (MAUDE) database. Adverse event reports are classified by the reporter as in...

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Bibliographische Detailangaben
Veröffentlicht in:JAMA Intern Med
Hauptverfasser: Lalani, Christina, Kunwar, Elysha M., Kinard, Madris, Dhruva, Sanket S., Redberg, Rita F.
Format: Artigo
Sprache:Inglês
Veröffentlicht: American Medical Association 2021
Schlagworte:
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC8314174/
https://ncbi.nlm.nih.gov/pubmed/34309624
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2021.3942
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