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
A pin hole was detected in the foil pouch of a device retained at smith & nephew from the investigational testing study. there is a low probability that the pin hole in the foil pouch will be identified by the surgical staff. the pin hole in the package may cause temporary or medically reversible adverse health consequences.