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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Edwards lifesciences has discovered that the subject devices were shipped into canada in error without health canada compliance status under the licensing investigational testing or special access provisions of the medical devices regulations. in addition some lots of the devices included instructions for use applicable to a 3 cm balloon device not the 4 cm balloon configuration of the subject devices.