Alerta De Seguridad para INTRODUCTOR PREFACE - REGISTRATION NUMBER ANVISA: 10132590509 / Venc. Registration: 12/4/2010

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

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    Biosense Webster recommends that the Preface Insert is not used with the NAVI-STAR Diagnostic and Ablation Catheter (THERMOCOOL MODEL) or any 8 French or larger catheter. The Company forwarded to the Technovigilance Unit / ANVISA a list containing the identification of all the customers for which the products in question were sent, as well as notification of corrective action to all of them (letter). Anvisa through the Technovigilance Unit will be accompanying the case, in order to ensure that the health products marketed in Brazil have the safety and efficacy necessary for the good performance of the product.
  • Causa
    Complaints related to a partial separation or release of the preface introducer's radiopaque tip during the use of the device in the left atrium when in conjunction with the navi-star diagnostic catheter and navi-star ablation (thermocool model) - note: there was surgical intervention for one of the cases. lots involved: 3078567,13082796,13085573,13085574, l0106234, l0106285, l0205091, l0205143, l0205143, l0206191, l0206234, l0304057, l0306043, l0306063, l0306158, l0306159, l0306160 l0405243, l0405331, l0505078, l0505137, l0705056, l0705114, l0905120, l1005041 l1005140, l1104268, l1205168,13091447,13078567,13078567, l0306208, l0405243 l0405331, l0405346, l0405347, l0505078, l0705056,13099291, l0405331, l0505078 l0205143,13082796, l0106131 , l0106132, l0106234, l0205143, l0206125, l0405331 l0405332, l0405346, l0505078, l0505137, l0605214, l0705056, l0705114, l1005041 l1005140,13078567, l0106234, l0206125, l0206234, l0305043, l0306043, l0306158 l0306208, l0405331, l0405346, l0505078, l0505136, l0505137 and l0705056.
  • Acción
    Biosense Webster is conducting corrective action through the Market Notice regarding the defect that may occur with the product. In BRAZIL there is a registry of import and distribution by JOHNSON & JOHNSON PRODUCTOS PROFISSIONAIS LTDA of the product codes involved in this corrective action. The Company J & J; informs that it has blocked for sale all lots of the affected codes that are in stock and placed the blocked quantities in quarantine./////////The Company through correpondencia of nº 693/2006 - dated of 19 of December 2006, informs that it is proceeding with the collection of lots involved in the Brazilian market.


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