Events

Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Ventura Biomédica Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1989
  • Date
    2016-09-08
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.