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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Potential health risk to patients undergoing cardio pulmonary by-pass surgery when using the embol-x glide protection system. the tip of the cannula may be deformed. if the defect is not noticed during preparation when force is applied to the tip during insertion or removal it may lead to a separation and embolize.