Events

Alerta De Seguridad para Wallstent endoprosthesis with Unistep release system

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BOSTON SCIENTIFIC DO BRASIL 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
    864
  • Fecha
    2007-03-27
  • 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
    Product registered in Brazil under nº 10341350226
  • Causa
    Boston scientific do brasil ltda reported the voluntary market withdrawal of 136 batches of wallstent tips endoprosthesis with monorail release system - unistep, as it identified "that the products of the lots listed in the appendix (http://www.Anvisa.Gov. can be released with an excessive release force. in response to three product complaints related to this context, boston scientific corporation has initiated an investigation to establish the source of this problem. while this investigation is ongoing, we have determined that products manufactured during the month of october 2006 may be released with a release force greater than normal. since we have defined that release with increased release force may lead to a clinical risk to patients including, inter alia, a risk of prolonging the procedure and potential damage to the vessel, we have decided to initiate voluntary withdrawal from some batches of the product "carotid wallstent". ".
  • Acción
    The Company Boston Scientific do Brasil Ltda. sent a letter to all customers who received the affected products, guiding the discontinuation of use and segregation of the units affected by this voluntary withdrawal; requesting the completion and return of a verification and traceability form.

Device

Wallstent endoprosthesis with Unistep release system

Manufacturer

BOSTON SCIENTIFIC DO BRASIL LTDA
  • Source
    ANVSANVISA