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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This voluntary recall follows confirmation of a single user report from outside of canada which resulted in 3m identifying an unintended material (process liner) in the product. the presence of a process liner may prevent or impede the safe return of electrosurgical current following electrosurgical unit (esu) activation. this defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body due to increased impedance at the pad application site.