Events

Alerta De Seguridad para Surgical Surgical Lens, Registration nº 10201230077 - Lots 2149701; 2149801; 2299701; 2149802; 2299702; 2149803; 2149804; 2149805; 2299703; 2149707; 2149712; 2149807; 21498

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Embramac- Empresa Brasileira de Materiais Cirúrgicos, Indústria, Comércio, Importação e Exportação Ltda; Terang Nusa SDN BHD.

¿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
    1429
  • Fecha
    2014-09-26
  • 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
    The factory audit performed within the maintenance process of the Seal of Identification of Conformity demonstrated that the company changed the sterilization process for the product, being in disagreement with the information sent to ANVISA.////////// UPDATE: The company completed the field action, according to report sent on the date of 01/29/2015.
  • Causa
    Suspension of authorization for the use of the conformity identification seal by the product certification body (ocp) motivated by the factory audit where it was noted that the surgical gloves were sterilized by a different method from the product registration.
  • Acción
    Company shall initiate Field Action for the collection of products manufactured from the date of the last factory audit, held on April 23 and 24, 2014.

Device

Surgical Surgical Lens, Registration nº 10201230077 - Lots 2149701; 2149801; 2299701; 2149802; 22...

Manufacturer

Embramac- Empresa Brasileira de Materiais Cirúrgicos, Indústria, Comércio, Importação e Exportaçã...