Source:http://linkedlifedata.com/resource/umls/id/C1547650
NCI: An issue with quality, authenticity, performance, or/and safety of medication or medical device. The concept encompasses any problems that may occur during manufacturing, shipping, storage, or use of the medical product including but not limited to such concerns as suspect counterfeit product, product contamination, super potent or subpotent medication, defective item or its component, poor packaging or product confusion, questionable stability, device failure or malfunction, and labeling concerns.