Events

Alerta De Seguridad para LATEX GLOVE FOR NON-STERILE PROCEDURE (WITHOUT POWDER), Registration No. 10201230123

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
    1346
  • Fecha
    2014-01-21
  • 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 Technovigilance Unit will be monitoring compliance with the field action. ////// UPDATE - 08/13/2014 - The company sent a report on the conclusion of the product collection action. 421,700 units were collected. The products collected and those in the company's inventory were sent to the company Momento Engenharia Ambiental for waste treatment, according to certificate nº 34499/2014.
  • Causa
    Suspension of authorization for the use of the identification seal of compliance by the product certification body (ocp) motivated by the failure in the semi-annual maintenance tests, according to reports ela / l-238.899 / 13; ela / l-240.743 / 1/14, issued by the ocp.
  • Acción
    Company should trigger Field Action. ///// UPDATE - 08/13/2014 - The company finalized the field action.

Device

LATEX GLOVE FOR NON-STERILE PROCEDURE (WITHOUT POWDER), Registration No. 10201230123

Manufacturer

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