Events

Alerta De Seguridad para COSEAL 2ml and COSEAL 4ml. Registration Anvisa 80145240375. Lots under risk: COSEAL 2ml: HA130719 and HA140448; COSEAL 4ml: HA130322, HA130637, HA130721 and HA130919.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BAXTER HOSPITALAR 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
    1409
  • Fecha
    2014-08-11
  • 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
    The product may exhibit reduced effectiveness due to failure to form the hydrogel, or even a hydrogel with mechanical resistance. If the product fails to form hydrogel or the hydrogel formed has an inappropriate (mechanical resistance) during a surgical procedure, the surgeon should use a new product kit or adopt an alternative surgical method. Additional information at http://portal.anvisa.gov.br/wps/wcm/connect/29102a80451087f1936fb7c2afb947e8/Message+of+Alerta_VENDA.pdf?MOD=AJPERES #### UPDATED ON 08/18/2017, the documentations of the action field sent by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Causa
    The effectiveness of the product may be compromised, given that tests carried out by the company have detected results below the specifications regarding the validity of the product.
  • Acción
    BAXTER HOSPITALAR LTDA is collecting the product (affected batches described above). Do not use the product at risk and identify the hazardous units in your stock, segregate them and contact BAXTER or distributor for return purposes. For details on how to proceed, check additional information in the Alert Message posted by the company: http://portal.anvisa.gov.br/wps/wcm/connect/29102a80451087f1936fb7c2afb947e8/Messagem+de+Alerta_VENDA.pdf?MOD=AJPERES

Device

COSEAL 2ml and COSEAL 4ml. Registration Anvisa 80145240375. Lots under risk: COSEAL 2ml: HA130719...

Manufacturer

BAXTER HOSPITALAR LTDA.