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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As a result of product quality monitoring it was brought to our attention that there might be a small perforation in the sterile pouch of these products. an investigation revealed this small perforation potentially occurring due to manufacturing related causes. as a result there is a potential for the pouch integrity to be compromised which may result in compromised sterility of the product. the patient risk is that if the compromised product is used in surgery it may result in an increased chance of infection for the patient.