Events

Alerta De Seguridad para BROCKENBROUGHT ADULT NEEDLE. ANVISA Registration No. 10339190097 ;. BROCKENBROUGHT PEDIATRIC NEEDLE. ANVISA Registration No. 1033919009.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC COMERCIAL LTDA.

¿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
    1239
  • Fecha
    2013-04-03
  • 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 company effectively started the field action on 03/22/2013, with code FA-570. For additional clarification please refer to Resolution Anvisa RE n ° 4,856 of November 12, 2012, available at http://portal.anvisa.gov.br/wps/wcm/connect/5c18c0004f214e56b56fbdc88f4b6a31/RE_4.8562_2012.pdf?MOD=AJPERES . #### Update (07/26/2013): The company reported having collected a total of 49 units of the products at risk (termination of action on 07/24/2013).
  • Causa
    Problems related to product sterility.
  • Acción
    Suspension throughout the national territory of the importation, disclosure, distribution, marketing and use of all lots of the aforementioned products, as well as the collection of all its existing units in the market.

Device

BROCKENBROUGHT ADULT NEEDLE. ANVISA Registration No. 10339190097 ;. BROCKENBROUGHT PEDIATRIC NEED...

Manufacturer

MEDTRONIC COMERCIAL LTDA
  • Source
    ANVSANVISA