Alerta De Seguridad O Notificaciones De Seguridad para In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products

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 CooperSurgical.

¿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
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    MHRA was made aware by the supplier of gentamicin sulphate API, used in the manufacture of IVF media and associated products, that some batches contained higher than expected levels of histamine due to a change in supplier. It should be noted that histamine is an impurity normally found in gentamicin in low levels because of the manufacturing process.MHRA and the Human Fertilisation & Embryology Authority (HFEA) have worked together to determine whether any risk may have occurred while using affected products in IVF procedures. This included getting advice from experts at the Association of Clinical Embryologists (ACE) and an expert in immunology. The risks, if any, from the increased histamine levels could not be determined from the available scientific literature, therefore this MDA has been published to ensure users are aware of the issue, so they can contact the manufacturer, HFEA, or ACE if they have any concerns.Affected products (all batches) were manufactured from 07/11/2016 to 30/10/2017.Products still within their expiry date were distributed from 07/04/2017 to 18/10/2017.
  • Causa
    Manufactured by coopersurgical: specific batches of products were manufactured with increased histamine levels in the gentamicin sulphate.
  • Acción
    Identify affected devices in your inventory (listed in the appendix) and return these to CooperSurgical for a replacement. Ensure all relevant healthcare professionals are aware. If after reviewing this notice you have further technical questions or concerns please contact your sales representative at CooperSurgical. If after reviewing this notice you have further clinical questions or concerns please contact your Human Fertilisation and Embryology Authority (HFEA) Inspector, or the Association of Clinical Embryologists (ACE). If any adverse events occur relating to these products, please report this to MHRA via Yellow Card or the relevant devolved administrations (Scotland, Wales and Northern Ireland).


  • Modelo / Serial
  • Descripción del producto
    Please refer to pages 5-10 in the MDA for details on the batches affected and additional unique item identification information.
  • Manufacturer


  • Dirección del fabricante
    For all products:Andrew Millward CooperSurgical UK Hamilton House Mabledon Place London WC1H 9BB Tel: 07496 719651Email: or
  • Empresa matriz del fabricante (2017)
  • Source