Alerta De Seguridad para Confidence Spinal Cement System Kit

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

¿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
    2013-04-19
  • Fecha de publicación del evento
    2013-04-19
  • 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: depuy synthes confidence spinal cement system kit medical device manufacturer, depuy synthes spine has issued a field safety notice concerning confidence spinal cement system 7cc kit [2839-07-000], confidence spinal cement system 11cc plus kit [2839-10-000], confidence spinal cement system kit [2839-13-000] with the following lot numbers: confidence spinal cement system 7cc kit: hpbbwt, hpdbfy confidence spinal cement system 11cc plus kit: hpbb0k, hpbb3c, hpcb7j, hpdbd6, hpbb0l, hpbb3d, hpcb7w, hpdbf0, hpbb0m, hpbb3f, hpdbbc, hpdbg4, hpbb0n, hpbbwh, hpdbbd, hpdbgb, hpbb0p, hpbbwj, hpdbbk, hpdbgc, hpbb0t, hpbbwl, hpdbbl, hpdbgj, hpbb19, hpbbz8, hpdbby, hpdbgm, hpbb27, hpbbzd, hpdbcd, hpdbgn, hpbb29, hpbbzn, hpdbcf, hpdbgy, hpbb2b, hpcb7b, hpdbd0, hpbb2c, hpcb7c, hpdbd3, hpbb2g, hpcb7h, hpdbd4 confidence spinal cement system kit: hpbb0b, hpbbwm, hpcb75, hpccbn, hpbb0r, hpbbwp, hpcb7d, hpdbbv, hpbb28, hpbbz7, hpcb7f, hpdbcg, hpbb2d, hpbbzf, hpcb7t, hpdbd1, hpbb2f, hpbckh, hpcb7v, hpdbd5, hpbb4r, hpbdl9, hpcb8g, hpdbf9, hpbbv1, hpcb67, hpcblc, hpdbgh, hpbbwg, hpcb68, hpcbm1, hpdbgk, hpbbwk, hpcb74, hpccbm, hpdbgl according to the manufacturer, complaints have been received involving product currently in distribution in which the customer reports that during injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. this could result in surgical delay in order to prepare another kit or termination of the procedure earlier than intended which could result in the need for the patient to undergo additional anesthesia as the result of another surgical procedure. the manufacturer advises users to remove the affected products from service and contact the local supplier to arrange product return, credit, and/or replacement. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 april 2013.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: DePuy Synthes Confidence Spinal Cement System Kit
  • Manufacturer

Manufacturer