Events

Alerta De Seguridad para ProTime Microcoagulation System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por International Technidyne 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
    2012-06-28
  • Fecha de publicación del evento
    2012-06-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120627c.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: protime microcoagulation system the health canada posted a medical device recall notice concerning protime microcoagulation system, manufactured by international technidyne corporation. the affected model is protimepro and the affected lot is v-71458. according to the notice, a limited number of protime instruments were manufactured with a component that may contribute to a small decrease in performance and may cause inconvenience. the affected instruments have a potential to yield either an error code (no test) or a slightly lower than actual pt/inr result when the inr is greater than 3.5. for details, please refer to health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/ recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 28 jun 2012.

Device

ProTime Microcoagulation System

Manufacturer

International Technidyne Corporation