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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Sorin group italia has received one problem report regarding the perceval s valve post dilation balloon catheter (size m). after the post dilation procedure the blue reference circle (depth marker ring) which is intended to provide a reference to the surgeon to assure proper positioning of the valve was found to be displaced on the catheter tip. this may occur when the plastic tube that protects the balloon is removed.