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.
데이터 추가 비고
원인
Edwards lifesciences discovered that the flow rate of this device was incorrectly stated on the box (case) label as 3 ml/hr but was correctly stated on the unit pouch label as 30 ml/hr. this error was limited to the two lots stated.