Alerta De Seguridad para Commercial Name: External Drainage Catheter Antimicrobial LCR ## Record Number: 10175060026 ## Technical Name: Drainage System ## Risk Class: IV (Maximum Hazard) ## Models: 04019724- Antimicrobial LCR External Drainage Catheter - Adult Model , 04019725 - LCR Antimicrobial External Drainage Catheter - Neonatal Model

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.

Recommendations: 1. Segregate products in stock; If you wish to notify technical complaints and adverse events, please use the following channels: Notivisa: Notices of adverse events (AEs) and technical complaints (QT) for products subject to Sanitary Surveillance should be sent to the manufacturer for later disposal (de-characterization / destruction) made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link ## UPDATE ## Field Action Closing: 12/12/2016. According to the report sent by the company, the products collected from customers and those that were in the company's stock were decharacterized.