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
While performing packaging integrity validation package failures in the pt-5558aftu-ds and 5120-25 product packages occurred. byron medical determined that the risk to public health while minimal was sufficient to remove the product from the field.