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
The holding pin on the retractor frame was reported as unscrewing and falling out. if this were to occur while the retractor is in use the retraction will not be affected but the fallen screw has the potential to enter the surgical wound undetected. this may result in an un-retrieved device fragment.