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Glossary

Use error

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An act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user. This includes slips, lapses and mistakes. However, an unexpected physiological response of the subject does not in itself constitute a use error.

Other glossary definitions

U

Unanticipated death or unanticipated serious injury

A death or serious injury is considered unanticipated if the condition leading to the event was…

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E

Emerging Safety Issue

A safety issue considered by a marketing authorization holder to require urgent attention by the…

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