Alerta De Seguridad para STERILE FIXING SYSTEM FOR BIOPLATE NEUROCIRURGY. Anvisa Registry: 80145900964. Lots Affected in Brazil: 1000, 1075, G03211108, G03241108, G03251108, G03261108, G03431208, G03630409, G03660409, G03740509, G03820609, G03830609, G03920709.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson Medical Brasil.

¿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
    1021
  • Fecha
    2010-05-28
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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 is following up on this case.
  • Causa
    Envelope seal width of some product packaging is out of specification, which may compromise product sterility.
  • Acción
    Johnson & Johnson Ltda has already begun collecting affected lots. If you have the affected product in stock and have not yet been contacted by Johnson & Johnson or any of its distributors, please segregate the product (identify it correctly so that it is not inadvertently used) and contact the company. If a patient has recently received the implantable article (under risk), it should be monitored.

Manufacturer