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
Terumo cardiovascular systems is aware of some users operating a terumo advanced perfusion system 1 with a modified cable to connect the system to an occluder for the modular perfusion system 8000. the cable is not specified for use with terumo system 1 and its use in this manner constitutes an off-label use.