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
Davol inc. has identified certain product code / lot number combinations of phasix mesh that contain instructions for use (ifu) with indications other than those licensed by health canada. the minor variation in the product information has no effect on the safety and efficacy of the product.