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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Notice advising users of updates to the ifu for the lapsac surgical tissue pouch to remove morcellation from the intended use warnings and the instructions for use and to add a contraindication. this communication is for informational purposes only and no devices need to be returned. it is intended that all future devices will include the updated ifu. sales of the device have been suspended until the new ifu can be included with the device.