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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To inform customers about updates to the instructions for use (ifu) for the listed gelatin sealed products. these updates now mandate soaking prostheses/patches in sterile saline solution for 5 minutes prior to implantation and include information on the use of formaldehyde in the manufacturing process.