Events

Alerta De Seguridad para Autogen and Dynagen

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
    2015-06-03
  • Fecha de publicación del evento
    2015-06-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150603.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 autogen and dynagen medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its implantable defibrillators, autogen and dynagen. [model: i) model g150 dynagen crt-d; ii) model d020 dynagen mini icd; iii) model g172 autogen crt-d; iv) model d044 autogen mini icd. serial numbers: i) sn100195, sn100153; ii) sn100079, sn100121; iii) sn100476, sn100550; iv) sn100197, sn100292]. the manufacturer forwarded eight devices to avalon medical international s.A. for product registration purposed in venezuela. these devices were labelled “not for human use”. the manufacturer learned both through a venezuelan doctor and the sub-distributor in venezuela that four of the devices were implanted in patients in venezuela. the manufacturer later determined that the implanted devices are in fact suitable for use in humans. the manufacturer requires all affected users and distributors to establish mechanisms to prevent the above-mentioned situation from happening again. 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 03 june 2015.

Device

Autogen and Dynagen
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific Autogen and Dynagen
  • 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