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
Biocompatibles uk ltd. is notifying customers of four additional potential complications that were not implemented in the instruction for use document supplied with the product dc bead m1 as agreed to with health canada on october 18 2013. these complications were: liver abscess post embolization syndrome pancreatitis and tumor rupture.