Alerta De Seguridad para Animas Insulin Pump

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

¿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
    2012-07-25
  • Fecha de publicación del evento
    2012-07-25
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: animas insulin pump the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device safety alert concerning animas insulin pump manufactured by animas corporation. according to animas, some patients experienced gradual wear of their insulin pump keypad that led to damage, such as tearing or peeling of the edge of the keypad from the pump. therefore, animas has improved the durability of the insulin pump keypad, which includes the ok button, up arrow/ down arrow buttons, and the contrast button. the manufacturer advised all animas insulin pump users to examine their insulin pump keypad for wear or damage on a regular basis, as part of the routine process of pump inspection. animas provides a warranty for a period of four years from the date of purchase in most cases. if a customer has a confirmed issue related to the keypad and he/she is covered by the animas warranty, animas will replace the pump at no charge. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Animas Insulin Pump
  • Manufacturer

Manufacturer