Events

Retiro De Equipo O Alerta De Seguridad para Surgical nets: Ethicon Physiomesh Flexible Composite Mesh composite flexible mesh

Según Ministry of Health of the Republic of Belarus, este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en Belarus que fue producido por Johnson & Johnson International (Johnson & Johnson Medical GmbH plant in Germany), BELGIUM.

¿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
  • Número del evento
    ИМ-7.100844
  • Fecha
    2016-06-28
  • País del evento
    Belarus
  • Fuente del evento
    MHRB
  • URL de la fuente del evento
    https://www.rceth.by/ru/Safety/MedSafety
  • Notas / Alertas
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Notas adicionales en la data
  • Causa
    The manufacturer, on its own initiative, decided to implement a voluntary global recall from the medical device market. the reason for the global recall from the market was the analysis of unpublished data, carried out at the request of the ethicon medical safety team by two independent registries in the field of hernia treatment (the german herniamed registry and the danish hernia database dhdb). the rate of relapses / reoperations after laparoscopic surgery to remove ventral hernias using medical devices was higher than the average recurrence rate among patients in these registers.

Device

Surgical nets: Ethicon Physiomesh Flexible Composite Mesh composite flexible mesh

Manufacturer

Johnson & Johnson International (Johnson & Johnson Medical GmbH plant in Germany), BELGIUM