Alerta De Seguridad para Commercial Name: External Drainage Catheter LCR Ventura /// Technical Name: Drainage System /// ANVISA Registration Number: 10175060016 /// Hazard Class: IV - Maximum Risk /// Model Affected: LCR 600A (Adult Model) , LCR 600N (Neonatal Model) and LCR 600H (Hemovent) /// 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
    1986
  • Fecha
    2016-09-14
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Discontinue use, segregate affected products and return them to the manufacturer. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be 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 closure: 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.
  • Causa
    Product outside the design specifications and in disagreement with the anvisa registration. ventura biomédica included a clamp, which is in disagreement with the project of the product and with its registration with anvisa.
  • Acción
    Field Action Code 205/2016 triggered under the responsibility of Ventura Biomédica Ltda. Company is performing recall of the affected products.

Manufacturer