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
Although the product labeling identifies the catheters as "soft rubber" the natural rubber latex caution statement ("caution: this product contains natural rubber latex which may cause allergic reactions") was not printed on the product label. if a person with a latex sensitivity comes into contact with the latex component of the product an allergic reaction could occur.