Events

Alerta De Seguridad para XATC RAPID EXCHANGE CAROTID SYSTEM. Lots: 495332, 495334, 496457, 496909 and 497924.

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

¿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
    908
  • Fecha
    2008-03-31
  • 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 Abbott Laboratories do Brasil Ltda, up to now there have been two reports of failure associated with the problem (both outside Brazil), none of which presented a risk of injury to the patient. The risk occurs only at the time of implantation and there is no risk for those patients previously implanted with the stent, according to information presented by the company.
  • Causa
    Possibility of failure of the alloy on the catheter shaft of some product units, which may lead, in some cases, to incomplete release of the stent.
  • Acción
    Abbott Laboratories of Brazil Ltda reported that only 2 lots of the product (lots 497924 and 496909) were imported into Brazil, for a total of 53 units. Of these, all units in lot 496909 (18 stents) were not distributed by the company and of the 35 units in lot 497924, 24 units were already blocked to be returned. Abbott Ltda is supplying the remaining 11 units of the product. #### Update (04/28/2008): Abbott Laboratories of Brazil Ltda informed the Anvisa Technological Monitoring Unit on 04/17/2008 that it has already received the 11 remaining units in the Brazilian market for the XATC Stent, lot 497924. In this way, the company informed UTVIG that it considers the collection of the product closed.

Device

XATC RAPID EXCHANGE CAROTID SYSTEM. Lots: 495332, 495334, 496457, 496909 and 497924.

Manufacturer

MEDNOVA LTD
  • Source
    ANVSANVISA