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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Molnlycke health care canada is reporting a label defect in their product mepilex border 7.5 cm x 7.5 cm. the defect is that an incorrect pictogram on the back of retail package identifies the non-critical dimensions for the inner wound pad to be 6.5 cm x 6.5 cm when the actual dimensions are 4.5 cm x 4.5 cm. internal investigations have revealed there are no other defects with this product. the identified defect has no impact on product integrity sterility safety or efficacy.