Events

Alerta De Seguridad para Ultraflex Tracheobronchial Covered Distal Release Stent System

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
    2016-03-22
  • Fecha de publicación del evento
    2016-03-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160322b.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 ultraflex tracheobronchial covered distal release stent system medical device manufacturer, boston scientific, has issued a medical device safety alert concerning ultraflex tracheobronchial covered distal release stent system [material number: m00576550; lot number: 18876596; expiration date range: 1 february 2018]. the manufacturer has become aware that the incorrect stent size has been packaged in a single lot of ultraflex tracheobronchial covered distal release stents labeled with 12mm outer diameter. the use of an undersized diameter stent may increase the risk of stent migration in a stent that is not intended to be removed. if the stent were to migrate the tracheobronchial stricture may not be effectively dilated and the patient may experience coughing, difficulty breathing and tissue damage. in addition, the removal of the migrated stent may require an additional procedure. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions posted on 22 march 2016.

Device

Ultraflex Tracheobronchial Covered Distal Release Stent System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific Ultraflex Tracheobronchial Covered Distal Release Stent System
  • 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