Events

Alerta De Seguridad para 10362890006 - Neonatal Poly-Brasino Two-Way Device

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.

¿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
    1017
  • Fecha
    2010-04-26
  • 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
    This sanitary measure was taken based on the Single Sample Fiscal Analysis Report No. 38.00 / 2010 issued by LACEN / PR, which found that inside the packaging of the NEONATAL PRODUCT OF TWO-WAY POLI-BRASINO there was no equipment for neonatal use, but for use in other age groups.
  • Causa
    Suspension of distribution, commerce and use, throughout the national territory, as well as the collection of lot 200209a of the neonatal device of two-ways poli-brasino, imported by kdl comércio de produtos médico-hospitalares ltda, located at rua eduardo froner nº 850, parque cid. brasília, guarulhos - sp.
  • Acción
    According to routine UTVIG / NUVIG / ANVISA, the company was asked to keep the UTVIG informed and updated of the progress of the batch process 200209A.

Device

10362890006 - Neonatal Poly-Brasino Two-Way Device

Manufacturer

ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD