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 device's wings may partially detached from the efx shield during use. the wings are secured to the device at two points therefore they are not completely detaching from the device. the partial detachment makes removal of the device from the patient more difficult and there is potential the incision site may need to be enlarged in order to remove the device.