" /> Inadequate Instructions for Non-Healthcare Professional - CISMeF





Preferred Label : Inadequate Instructions for Non-Healthcare Professional;

NCIt synonyms : Confusing Instruction for Medical Device Use;

NCIt 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 a medical device including verbal instructions related to identification, technical description and use of the device provided by a medical device manufacturer that vary from the standard of medical care in a given environment.;

Alternative definition : FDA: 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.;

FDA table : Device Problem Code (Appendix B);

Codes from synonyms : 2956;

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31/05/2025


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