Events

Safety Alert for 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)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by IMPORT MEDIC IMPORTAÇÃO E EXPORTAÇÃO LTDA; BIOSIL LTD..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1852
  • Date
    2016-03-22
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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