Events

Alerta De Seguridad para Key Empirical Dynamometer, Registration 80136990682, Lot / Series 51643928, 51644510, 51653452, 51672690 and 51809478

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
    1631
  • Fecha
    2015-07-06
  • 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
    According to the manifestation of the company, the purpose of this communication is to prevent occurrences of product breakdown.
  • Causa
    The company informs that the release mechanism of the torque switch supports the application of a defined force of 2.8nm. if the applied force is greater than the defined force, the screw break may occur. the torque wrench is made up of three parts and can be dismantled for cleaning. assembly and disassembly of the torque switch are described in the product use manual.
  • Acción
    The company instructs you to follow the assembly and disassembly instructions described in the Product Use Manual and detailed in the Appendix - Customer Letter.

Device

Key Empirical Dynamometer, Registration 80136990682, Lot / Series 51643928, 51644510, 51653452, 5...

Manufacturer

Laboratórios B. Braun S.A.; Aesculap AG