Events

Alerta De Seguridad para Trade name: Broca Esf. Diam. Hi-Line Great. Thick IT / Drill Esf. Diam. Hi-Line Great. Thick Tip Technical Name: Broca Esf. Diam. Hi-Line Great. Thick IT / Drill Esf. Diam. Hi-Line Great. Affected serial numbers: 51745118, 51649830, 51708484, 51838047, 51634741 and 51293170. Note: The unit of lot 51293170 was used during the disclosure project. of the product in 2005, and is not distributed to the customer.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Laboratórios B. Braun S.A.; Aesculap AG.

¿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
    2267
  • Fecha
    2017-04-12
  • 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
    Interruption of the use of said lot numbers, segregation thereof and information to Laboratorios B. Braun SA, for collection.
  • Causa
    During surgery, the possibility of releasing particles from the diamond covering to the situs was observed, which may not be perceived by the user.
  • Acción
    Field Action Code AC / 02/2017 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for later return to the manufacturer.

Device

Trade name: Broca Esf. Diam. Hi-Line Great. Thick IT / Drill Esf. Diam. Hi-Line Great. Thick Tip ...

Manufacturer

Laboratórios B. Braun S.A.; Aesculap AG