Events

Alerta De Seguridad para STERILE OPERATING FIELD, 13 WIRES WITH 05 UNITS lot 0477 - Record nº 80037490007

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por América Medical 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
    1580
  • Fecha
    2015-05-15
  • 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 requests that the product should not be used and that the services that may have units of this lot should contact the company so that it can arrange the collection by means of the email gqt@americamedical.net
  • Causa
    Disappearance in the product aspect test sterile operating field, according to the single sample analysis report 114.198945, issued by lacen ba, for lot 0477.
  • Acción
    The Sanitary Surveillance of the State of Minas Gerais published a Notice of Interdiction of Caution of the Collegiate Management of the Superintendence of Sanitary Surveillance / 09 / DVMC / 2015, on January 23, 2015. The company is performing the product collection.

Device

STERILE OPERATING FIELD, 13 WIRES WITH 05 UNITS lot 0477 - Record nº 80037490007

Manufacturer

América Medical Ltda
  • Source
    ANVSANVISA