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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Gmd is recalling this product because the model 1010 sling assembly's sheath and mesh/sheath/sleeve bonding area design may have caused or contributed to certain adverse events including voiding dysfunction/retention which in some cases required sling revision or removal.