Events

Alerta De Seguridad para 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Ventura Biomédica Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1989
  • Fecha
    2016-09-08
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    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.
  • Acción
    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.