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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Draeger became aware of an incident where a user suffered an acute allergic reaction after using a draeger latex test lung. the user did not suffer permanent injury. it was discovered that the breathing bag that belongs to the test lung and other latex breathing bags are labelled "nr". although this is the standard abbreviation for natural rubber (latex) this labelling does not comply with the applicable international standards for medical devices.