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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The ec certificate of all medical devices from the manufacturer silimed who is a subcontractor to coloplast has been temporarily suspended by their notified body due to particles found at the surface of some breast implants. there is no indication that these issues would pose a threat to the implanted person's safety. the suspension also affects vaginal stents placed on the market by coloplast. in line with recommendations from the authorities coloplast request that all affected devices with silimed as point of origin should be put in quarantine and that use of these devices should be ceased until further notice.