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 discovered at the o'hara site that operation manual cds for spectris solaris ep (ssep) were not sent to customers. the operation manual multilingual cd was intended to be placed on the product proposal which would have the manual shipped with the spectris solaris ep injector as a line item. the cd was never added to the product proposal.