Events

Alerta De Seguridad O Notificaciones De Seguridad para Burr hole probe cover with gel

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 Microtek Medical Europe.

¿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/2013/076
  • Número del evento
    CON329263
  • Fecha
    2013-10-24
  • Fecha de publicación del evento
    2013-10-24
  • 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/CON329263?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 exposure to endotoxin levels above acceptable limits if the ultrasound probe cover comes into contact with the central nervous system. the manufacturer has identified that the affected ultrasound probe covers have not undergone adequate endotoxin testing. microtek medical europe issued a field safety notice (fsn) dated 10 july 2013 but has not received sufficient confirmation from users that they have received and acted on this information.
  • Acción
    Ensure that relevant staff are aware of this Field Safety Notice. Identify all affected batches of these ultrasound probe covers. Quarantine all affected batches. Complete the recall response form and return it to Microtek Medical Europe as soon as possible. Follow the manufacturer’s instructions for returning the affected devices. Action by: Operating theatre staff and surgical staff Neurosurgery departments Spinal surgery departments Radiology departments Supplies departments

Device

Burr hole probe cover with gel
  • Modelo / Serial
  • Descripción del producto
    Ultrasound probe cover: Burr hole probe cover with gel. These ultrasound probe covers are disposable, single-use drapes. They are used as a cover for ultrasound probe scan heads and power cords, used for various surgical procedures, to provide a barrier over the equipment. Product reference (SKU number): 3688UK, PC3688, PC3688EU. Affected batch numbers are listed in the Field Safety Notice (FSN). Note that product ref (SKU number) 3688 is listed in the FSN but it is not for sale in the UK.
  • Manufacturer
    Microtek Medical Europe

Manufacturer

Microtek Medical Europe
  • Empresa matriz del fabricante (2017)
    Ecolab Inc
  • Source
    MHRA