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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Voluntary recall as a result of reported discoloration (residue) on the pins of the skin tensioner. kits are gamma stereilized so no risk of pathogens. residue on pin has iron and chloride compounds which is a result of the cleaning process used on pins. there are no long term hazardous side effected identified but possible skin irritation or localized skin allergic reaction may occur.