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 identified an increase in reports of introducer leaks from the hemostasis valve while being used in conjunction with the proplege peripheral retrograde cardioplegia device. reports indicate that there have been cases where more blood loss than would be expected occurred.