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
It was established at primary packaging that some obturators of one batch (size 06 lot 1000124104) can break when inserted into the outer cannula. there is a risk of broken fragments being inhaled into the lower respiratory tract.