VENOUS CANAL SARNS / ANVISA Registry n ° 80012280001 ;. ARTERIAL CANAL SARNS / ANVISA Registry n ° 80012280011. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.

The presence of loose fiber particles on the surface or within the cannula may be difficult to detect by users. Such particles may settle in the patient's vascular system, resulting in varying degrees of damage, depending on the size of the material, the location in which it was deposited, and the condition of the patient. Potential results include particle embolism or an inflammatory response that can cause blood clots, ischemia, or tissue death. #### UPDATED ON 08/18/2017, fieldwork documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.