Events

Alerta De Seguridad para SHER-I-BRONCH ENDOBRONCHIAL TUBE - Registered in Anvisa under the number 10342600018 - Models / Lots: See attached list.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Comercial Nacional de Produtos Hospitalares 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
    977
  • Fecha
    2009-08-31
  • 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
    Manufacturing problems were identified as of July / 2009. In Brazil no cases of adverse events involving this product have been reported up to the present moment. The completion of the collection action of this product is scheduled for October / 2009. Anvisa follows this action.
  • Causa
    The product manufacturer has announced that the plastic connection connecting the cover to the sher-i-swiv double swivel body may break partially or completely at certain points. breakage of this connection can cause it to be thrown into the tube or double swivel body, resulting in potential accidental aspiration of the part into the patient's lungs.
  • Acción
    The actions recommended to product users are as follows: (1) Find the products with the affected models / batches in your inventory and segregate them. (2) Return them to the dealer for disposal. (3) Contact the representative in Brazil: Comercial Nacional de Produtos Hospitalares Ltda. - Anny Caroline Di Rocco Santos - Phone: (011) 3385-9361 - e-mail: any@cnph.com.br.

Device

SHER-I-BRONCH ENDOBRONCHIAL TUBE - Registered in Anvisa under the number 10342600018 - Models / L...

Manufacturer

Comercial Nacional de Produtos Hospitalares Ltda.