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 Stryker Orthopaedics.

¿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 064 09 18 000
  • Fecha de inicio del evento
    2018-09-18
  • País del evento
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
  • 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
    Stryker orthopaedics ("stryker") has initiated a voluntary, lot-specific recall for the knee instrument referenced above. the intent of this letter is to list known hazards potentially associated with the use of the instrument and list any risk mitigation factors. issue: stryker has discovered that the outer sterile barrier of the above-referenced instrument and lot was not fully sealed. for the above-referenced instrument observed by stryker, the inner sterile barrier seal was intact. potential hazards: technical and medical assessments are currently underway to determine any potential hazards associated with the use of the instrument. additional communication will be forwarded upon completion of the internal investigation on this issue risk mitigation: according to the instruction for use (ifu) provided within each packaged component, the end user is instructed to inspect the package and seal for damage and, if present, to discard the device. as any damage to the packaging likely will be obvious to the end user, inspection and verification prior to transferring the device to the sterile field that both the outer and inner blister is acceptable, as per the ifu, may mitigate potential risk.

Device

  • Modelo / Serial
    Affected Catalog Number(s): 7650-2038A Affected Lot(s): SC22130X
  • Descripción del producto
    Non-active implantable device
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Representante del fabricante
    Al-Faisaliah Medical System, Riyadh (01) 2119999
  • Source
    SFDA