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
Two (2) affected lots may not perform as intended in that the device may malfunction during use and in rare cases the cartrdige may crack during use. one (1) injury was reported during use an enlargement of the incision with no further adverse patient impact.