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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In november 2015 during a review of historical intego sas testing it was discovered that documented test evidence related to 85 psi for 35 seconds could not be found. when the necessary testing was recently conducted some failures were found at three year simulated age testing. the failed samples exhibited leaks in the coil bond joint. there was no test failures of the samples at one year accelerated age. product is currently labeled with a 3 year shelf-life and thus needs to be corrected until this shelf-life can be re- established.