Events

Alerta De Seguridad para ENDOTRACHEAL TUBE PORTEX WITHOUT BALLOON PEDIATRIC SIZE, OF 2.0; 2.5; 3.0 and 3.5mm - Registered at Anvisa under the number 10150470013.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Cirúrgica Fernandes - Comércio de Materiais Cirúrgicos e Hospitalares Sociedade Limitada..

¿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
    989
  • Fecha
    2009-10-05
  • 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
    More details of the collection access www.cirurgicafernandes.com.br or request information by e-mail: recolhimento@fernandes.com.br. Anvisa is following this action. Attachments in: http://www.anvisa.gov.br/tecnovigilancia/alertas/index.htm
  • Causa
    The manufacturer of the product announced that variations in its industrialization process resulted in some tubes with internal diameter slightly lower than the specifications on the product labels and could cause difficulties in the removal of secretions and other adverse events to patients. while acknowledging the potential risk in using the products, the company claims that it has not received any notice of occurrence of any adverse events involving them.
  • Acción
    The actions recommended to users of the product are as follows: (1) Immediately stop the use of products listed in the attached list; (2) Locate products with the affected models / batches in your inventory and segregate them. (2) Return them to the dealer for disposal. See attachments.

Device

ENDOTRACHEAL TUBE PORTEX WITHOUT BALLOON PEDIATRIC SIZE, OF 2.0; 2.5; 3.0 and 3.5mm - Registered ...

Manufacturer

Cirúrgica Fernandes - Comércio de Materiais Cirúrgicos e Hospitalares Sociedade Limitada.