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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This recall has been initiated due to 'pressure percentage proximal decrease not being within the optimal range specified for specific styles. when the product is out of range for pressure percentage it may not effectively manage poor circulation in the lower extremity as intended. this may only have an effect on a small percentage of the population.