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.
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The potential for a rare occurrence of a moderate injury has been identified. a laceration cut tear or abrasion to the skin on the back of the patient's lower leg could result in patients with frail skin if the leg is positioned at the opening between the thigh and foot sections or the thigh and head sections.