Events

Retiro De Equipo O Alerta De Seguridad para Confidence Spinal Cement System

Según Central Drugs Standard Control Organization, este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en India que fue producido por Depuy Spine Inc.

¿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
    Recall / Safety Alert
  • ID del evento
    31-608-MD/2009-DC (Re. Registration 2011)
  • Fecha
    2014-01-15
  • País del evento
    India
  • Fuente del evento
    CDSCO
  • URL de la fuente del evento
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notas / Alertas
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 recall data from the U.S. and India.
  • Notas adicionales en la data
  • Causa
    Voluntary recall has been initiated due to the reason 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 the cement. this could result in surgical delay which could result in the need for the patient to undergo additional anesthesia as the result of another surgical procedure. the another reason has been reported that , firm reported that the cement mixer used to prepare cement for surgery has been identified to not tum properly. the event may be described as the mixer being "jammed" or "stuck" and not able to turn which could result in surgical delay in order to prepare another kit or the inability to complete the procedure if an additional kit is not available thereby exposing the patient to addtiional anesthesia in another surgical procedure.
  • Acción
    Johnson & Johnson has ceased distribution of the product while evaluating appropriate corrective and preventive actions.

Device

Confidence Spinal Cement System

Manufacturer

Depuy Spine Inc