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
An anomaly identified with the al07368000 rectal retractor titanium white acetal which is included in the ct/ mr ring and tandem applicator al13017000. the rectal retractors have shown evidence that contaminates or fluids have entered into the center of the rectal retractor paddle across the pins or bottom rod areas. using a part in this condition could result in infection toxicity or allergic reaction.