Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Ventura Biomédica Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1982
  • Date
    2016-09-14
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    During inspection by entities of the national system of sanitary surveillance (snvs) it was evidenced that the company was manufacturing and marketing product in disagreement with the specifications of the project and in disagreement with its registration with anvisa.
  • Action
    Field action 204/2016 triggered under the responsibility of Ventura Biomédica Ltda. - CNPJ: 57.182.230 / 0001-36, which involved the immediate stoppage of the manufacturing and marketing of the product; communication to customers for blocking commercialization and use, recollection for later destruction / decharacterization.

Device

Commercial Name: External Drainage Catheter Antimicrobial LCR ## Record Number: 10175060026 ## Te...

Manufacturer

Ventura Biomédica Ltda.