Events

Notificaciones De Seguridad De Campo acerca de Nellcor Durasensor® (DS-100A) sensors\Product Code DS-100A

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Tyco Healthcare group LP.

¿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
    Field Safety Notice
  • Número del evento
    SN2010(17)
  • Fecha
    2010-12-22
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/counterfeit-covidien-nellcor-spo2-durasensor-(ds-100a)-sensors-22.12.2010&id=9f89f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The potential supply and use of counterfeit nellcor spo2 durasensor (ds-100a) sensors that are not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
  • Acción
    The IMB  advises that:  • All products in your possession should be checked using the details above to assess whether the product is genuine or counterfeit.  • If from your assessment you determine or suspect that you have product that is counterfeit, quarantine the product to ensure it will not be used and contact your local Covidien representative, who will be able to confirm if the product is authentic.  • If you identify that you have product that is counterfeit you should return any such affected product in your possession to the local Covidien representative and inform the IMB.  Further Information: All adverse incidents relating to a medical device should be reported to the:  Irish Medicines Board  Kevin O’Malley House  Earlsfort Centre  Earlsfort Terrace  Dublin 2  Telephone: +353-1-6764971  Fax: +353-1-6344033  E-mail: vigilance@HPRA .ie  Website: www.HPRA .ie  Enquiries should be addressed to:  Local Covidien Office:  Deirdre O’Connor at: 087 8168519  Mark Gray at: 087 6538087  Covidien Ireland  Block G, 1st Floor  Loughlinstown  Dublin  Please click here to download a pdf version of the safety Notice « View List Latest Information Provide Feedback   Page Attachments  - Advisory - Counterfeit Covidien Nellcor SpO2 RSS Feeds HPRA Notices RSS Feed

Device

Nellcor Durasensor® (DS-100A) sensors\Product Code DS-100A
  • Modelo / Serial
  • Descripción del producto
    Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors 22.12.2010
  • Manufacturer
    Tyco Healthcare group LP

Manufacturer

Tyco Healthcare group LP
  • Source
    HPRA