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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Leaking septa have been observed in manufacturing and also in customer complaints. health canada requested on december 16 2013 that "all users of the product" be notified of the situation an "informal notification" a "level ill recall". date problem was firstidentified: april 30 2012 how the problem was identified: during routine in-process leak inspection of product during manufacture. customer complaints: observed increased complaint rate for leakage during april-june 2012.