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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It has come to the attention of devicor medical products inc. that a mst1009 probe for the mammotome revolve biopsy device in a stereotactic application may have been mislabeled. it is a 10 gauge device with a 9 cm needle. in lot number f11537107d1 a mst1009 was in a mst0815 package for a single unit. this single unit was identified by a customer and returned.