Events

Safety Alert for Trade Name: SISTEMA ESSURE Technical Name: Female Contraceptive Devices ANVISA Registration Number: 80274190001 Hazard Class: IV - Maximum Risk Affected Models: ESS305 Affected Lot Numbers: All lots

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Comercial Commed Produtos Hospitalares Ltda; Bayer Health Care LLCI.

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
    2208
  • Date
    2017-02-23
  • 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
    Products in stock at distributors, hospitals or clinics should be segregated in order to prevent them from being inadvertently implanted. Contact the company to receive detailed guidance on picking up non-deployed units. ### UPDATED ON 07/18/2017, published in the Official Gazette of the Federal Government on July 10, 2017, RESOLUTION RE 1.846, OF JULY 7, 2017 - Repeal Resolution RE 457 of 17 / 02/2017, published in the DOU nº 36 of February 20, 2017, Section 01, fl.35, which had determined the collection, suspension of the importation, distribution and commercialization, use and dissemination of the product ESSURE, registration ANVISA nº 80274190001, registration process nº 25351.350321 / 2007-88, imported and registered in Brazil by the company COMERCIAL COMMED PRODUCTOS HOSPITALARES LTDA, CNPJ: 02.643.718 / 0001-21. ### Alert 1908 correlates with alert 2208.
  • Reason
    Anvisa suspended the importation, distribution, commercialization, use and dissemination of the "essure system" product throughout the national territory (re 457, dated 02/17/2017 - dou no. 36 - section 1, dated 02/20/2017) , as well as determined the collection of units of the product that were not implanted.
  • Action
    Field Action Code 001/2017 triggered under the responsibility of the company CONERCIAL COMMED PRODUCTOS HOSPITALARES LTDA. Collection of units sold and not implemented.

Device

Trade Name: SISTEMA ESSURE Technical Name: Female Contraceptive Devices ANVISA Registration Numbe...

Manufacturer

Comercial Commed Produtos Hospitalares Ltda; Bayer Health Care LLCI
  • Source
    ANVSANVISA