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.
데이터 추가 비고
원인
Labelling changes have been made to synthes external fixation systems (small medium and large) related to magnetic resonance (mr) conditions as a result of changes in required testing protocols/standard to designate a product mr safe mr conditional and mr unsafe. metal devices are no longer identified as mr safe and as a result synthes external fixation systems are no longer labelled mr safe. the synthes external fixation systems are now identified as mr conditional.