Events

Alerta De Seguridad para Trade Name: NAGOR TEXTURIZED MAMMARY IMPLANT FILLED WITH GEL //// Models: EHP175 / EHP195 / EHP235 / EHP325 / EHP345 / EHP365 / EHP395 / EHP465 / EHP555 / EHP605 / EHP655 / EHP705 / EHP765 /// Registration: 80198390013 // Class risk: III //// Lots series: 097240/099115/099731/101597/101983/101984/102000/102011/102179/102180/102181/102182/102444/102445/102531/102664/102665/102713/102715/102759 / 102760/102761/102762/102767/102773/103094/103891 (map attached distribution)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por IMPORT MEDIC IMPORTAÇÃO E EXPORTAÇÃO LTDA; BIOSIL 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
    1852
  • Fecha
    2016-03-22
  • 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
  • Causa
    During the inmetro certification closure audit at the biosil ltd manufacturer's premises on 19 and 20/11/2015 it was evidenced by the audit that not all critical stages of production were performed at this plant. the manufacturer conducted product risk assessment comparing production, quality, safety and efficacy standards between the products manufactured at cumbernauld (certified) and ashby (non-certified). the study found that the products produced at the ashby biosil plant have the same production quality, safety and efficacy standards as the products produced at cumbernauld's biosil plant.
  • Acción
    Action code RNC 2242. Patient Clinical Record Survey.

Device

Trade Name: NAGOR TEXTURIZED MAMMARY IMPLANT FILLED WITH GEL //// Models: EHP175 / EHP195 / EHP23...

Manufacturer

IMPORT MEDIC IMPORTAÇÃO E EXPORTAÇÃO LTDA; BIOSIL LTD.
  • Source
    ANVSANVISA