Events

Alerta De Seguridad para CATETER THERMOCOOL SMARTTOUCH, Model - Thermocool Smarttouch Bi-directional and Thermocool Smarttouch Uni-directional, Registration nº 80145901380. Lots: See attachment

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 do Brasil Ind. e Com. de Prod. para Saúde 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
    1292
  • Fecha
    2013-09-04
  • 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
    The company reports so far, there have been no reports of injury or adverse events in patients as a result of this defect. However, an interruption in the flow of irrigation fluid has the potential to cause overheating of the ablation tip and formation of a burn or thrombus, which in turn may present a thromboembolic risk to the patient./////24/11 / 2014 - The company announced the closure of this field action. According to the company all the customers were contacted, being collected 145 units of the product.
  • Causa
    The company that owns the record reports that biosense webster, maker of the product, recently noticed an increase in reports of interruption of irrigation flow. an internal investigation has identified a defect in the production process, which may cause occlusion of the irrigation lumen.
  • Acción
    The company requests that the "Problem description" section be read carefully in the letter attached to this alert. - Immediately identify and separate all affected products to ensure that the product is not used. Keep a copy of this letter along with the THERMOCOOL SMARTTOUCH® catheter until all units are returned to Biosense Webster. - Sign and return the attached Voluntary Field Withdrawal Form, according to the instructions on the form. - Coordinate the return of all THERMOCOOL SMARTTOUCH® catheter units that may be in your inventory, according to the instructions on the Voluntary Field Withdrawal Certification Form. - Transmit this notification to everyone in your facility who needs to be informed. -Be careful of this notification until all affected products have been returned to Biosense Webster. - If any of the affected THERMOCOOL SMARTTOUCH® catheters have been sent to another facility, contact the facility to arrange for a return.

Device

CATETER THERMOCOOL SMARTTOUCH, Model - Thermocool Smarttouch Bi-directional and Thermocool Smartt...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda