Events

Field Safety Notices about Nellcor Durasensor® (DS-100A) sensors\Product Code DS-100A

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Tyco Healthcare group LP.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2010(17)
  • Date
    2010-12-22
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    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
  • Notes / Alerts
    "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."
  • Extra notes in the data
  • Reason
    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.
  • Action
    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
  • Model / Serial
  • Product Description
    Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors 22.12.2010
  • Manufacturer
    Tyco Healthcare group LP

Manufacturer

Tyco Healthcare group LP
  • Source
    HPRA