Events

Safety Alert for Commercial Name: Kompacto Ventura External Micro Sensor Kit Technical Name: Drainage System and Pressure Monitoring /// ANVISA Registration Number: 10175060015 /// Hazard Class: IV - Maximum Risk /// Affected Lot Numbers: See Distribution Map

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
    1989
  • Date
    2016-09-08
  • 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
    For products marketed from 08/14/2016, their commercialization and use should be suspended. The affected products must be segregated and returned to the manufacturer. ## UPDATE # Field action closure: 12/2/2016. 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
    Commercialization of the product with its expired registration with anvisa. the product registration was not revalidated due to the discontinuation of its manufacture by ventura biomédica.
  • Action
    Field Action Code FNC 195-2016 triggered under the responsibility of Ventura Biomédica Ltda. Company is performing collection of products marketed from 08/14/2016.

Device

Commercial Name: Kompacto Ventura External Micro Sensor Kit Technical Name: Drainage System and P...

Manufacturer

Ventura Biomédica Ltda.