Events

Alerta De Seguridad para Encore 26 Advantage Kit

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Boston Scientific.

¿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
  • Fecha
    2012-10-17
  • Fecha de publicación del evento
    2012-10-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121017.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: boston scientific encore 26 advantage kit medical device manufacturer, boston scientific, has issued a medical device safety alert concerning encore 26 advantage kit [catalogue no.: 04527-01, 04527-05] the manufacturer has discovered that users of the encore 26 advantage kits which were manufactured between 3 aug 2012 and 18 sep 2012 may experience difficulty in passing guidewires through the insertion tool which is included with encore 26 advantage kits. the difficulty to pass guidewires, especially j-tipped guidewires, through the insertion tool is caused by a lack of smoothness within the hub/hypo tube transition in some devices. this issue may lead to a clinically insignificant prolongation of the procedure upon attempt to insert a guidewire into the insertion tool but it not expected to cause increased risk of injury. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 17 october 2012.

Device

Encore 26 Advantage Kit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific Encore 26 Advantage Kit
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH