Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Ethicon Endo Surgery Inc.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 002 06 16 000
  • Fecha de inicio del evento
    2016-06-01
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9451
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Ethicon has initiated a voluntary product recall of ethicon physiomesh™ flexible composite mesh (for laparoscopic use) (“ethicon physiomesh™ composite mesh”). ethicon is recalling the product following an analysis conducted at the request of the ethicon medical safety team of unpublished data from two (2) large independent hernia registries (herniamed german registry and danish hernia database-dhdb). the recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh™ composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries. based on the currently available data, ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors. consequently, ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ethicon physiomesh™ composite mesh from the global market.

Device

ETHICON PHYSIOMESH Flexible Composite Mesh

Manufacturer

Ethicon Endo Surgery Inc
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Representante del fabricante
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA