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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It was discovered that the bills of materials for the packaging of the paradym dr and vr icd models manufactured by sorin crm s.R.L. for canada included a reference to an incorrect patient booklet the icd/crt patient booklet ref o263 instead of the correct booklet the icd patient booklet ref n582.