Events

Alerta De Seguridad para SFN PUNCH NEEDLE FOR TOTALLY IMPLANTABLE CATHETER SYSTEM - Registered at Anvisa under the number 10342600035 - Model SFN-A 0925 - Lot 09468.

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
    982
  • Fecha
    2009-09-21
  • 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 company informs that it has so far received no reports of adverse events related to the problem described. The cause of the problem is still under investigation. Anvisa is following this action.
  • Causa
    The company reports that, through customer complaints, it has been verified that there is a possibility that the stent will detach itself from the needle during its use and may cause potential harm to patients.
  • Acción
    The actions performed by the company were: (1) Tracking of affected lots traded; (2) Segregation of affected lots from stock; (3) Communication to customers. The actions recommended to users of the product are as follows: (1) Immediately stop the use of affected products; (2) Identify and segregate the affected products in their inventories; (3) Report the distributors or the holder to the collection - Mrs. Anny Caroline Camargo Di Rocco Santos - Fax 011-3385-9362 or by e-mails anny@cpnh.com.br and sac@cpnh.com.br

Device

SFN PUNCH NEEDLE FOR TOTALLY IMPLANTABLE CATHETER SYSTEM - Registered at Anvisa under the number ...

Manufacturer

COMERCIAL NACIONAL DE PRODUTOS HOSPITALARES LTDA.