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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The voluntary correction is due to a manufacturing variation in the grip assembly of the instrument which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain cannula reducer accessories.