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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An audit of the manufacturing process has discovered a variance in the construction of the model 5319-37 pads that may allow the patient to contact the underlying carbon fiber structure of the wilson frame which could lead to a pressure injury.