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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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Bibliografske podrobnosti
izdano v:JAMA Intern Med
Main Authors: Lalani, Christina, Kunwar, Elysha M., Kinard, Madris, Dhruva, Sanket S., Redberg, Rita F.
Format: Artigo
Jezik:Inglês
Izdano: American Medical Association 2021
Teme:
Online dostop: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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