Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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It was identified that during an injection there is a potential that a saline phase could not complete if the injection is started or resumed while a keep vein open (kvo) pulse is active. additionally a software revistion will be implemented to adjust the reminder behavior to ensure that if the injection phase is paused mannually the reminder timer resumes once the injection phase is resumed.