Events

Alerta De Seguridad O Notificaciones De Seguridad para Gastrostomy devices: Measuring device, Direct dilation kit, Balloon gastrostomy kit

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Medicina Ltd.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2014/032
  • Número del evento
    CON448005
  • Fecha
    2014-08-20
  • Fecha de publicación del evento
    2014-08-20
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON448005?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of infection as the balloon gastrostomy kit may contain out-of-date devices. the sterility of these devices cannot be assured. in addition, the safety and performance of these devices has not been properly evaluated and so the ce marking of all of these devices is invalid. medicina issued three field safety notices (fsns) in june 2014 but has not had sufficient confirmation that customers have received and acted on these notices.
  • Acción
    Do not use affected devices. Quarantine and return them to the manufacturer as described in the FSNs: Measuring device FSN Direct dilation kit FSN Balloon gastrostomy kit FSN For patients with gastrostomy catheters the MHRA currently considers that the benefits of continuing to use the device outweigh the risks of removal and replacement. Return the email / fax back form in the FSNs to the manufacturer. Personnel involved in the purchase, supply and distribution of these devices.

Device

Gastrostomy devices: Measuring device, Direct dilation kit, Balloon gastrostomy kit
  • Modelo / Serial
  • Descripción del producto
    Gastrostomy devices: Measuring device – product code: BM01 Direct dilation kit – product codes: DD12fr, DD14fr and DD16fr Balloon gastrostomy kit – product codes: EK12fr, EK14fr, EK16fr, EK18fr, EK20fr, EK22fr and EK24fr All batches. If relevant to you, the NHS Supply Chain Codes are as follows: Medicina Ltd product code NPC Product description DD12fr FWM1726 Gastrostomy Kit Direct dilation gastrostomy kit 12FR DD14fr FWM1727 Gastrostomy Kit Direct dilation gastrostomy kit 14FR DD16fr FWM1728 Gastrostomy Kit Direct dilation gastrostomy kit 16FR EK12fr FWM1729 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 12FR EK14fr FWM1730 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 14FR EK16fr FWM1731 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 16FR EK18fr FWM1732 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 18FR EK20fr FWM1733 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 20FR EK22fr FWM1734 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 22FR EK24fr FWM1735 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 24FR
  • Manufacturer
    Medicina Ltd

Manufacturer

Medicina Ltd
  • Empresa matriz del fabricante (2017)
    Luan Srl
  • Source
    MHRA