XE17P

Inadequate instructions for non-healthcare professional

Instruções inadequadas para não profissionais de saúde

Category

Definition

Problem associated with users being unclear and not able to follow any written, printed, or graphic matter that is affixed to device or its packaging with any matter that accompanies the device including verbal instructions related to identification, technical description and use of the device provided by the device manufactures that vary from the standard of medical care in a given environment.

Index Terms

Inadequate instructions for non-healthcare professional