Events

Safety Alert Or Field Safety Notices for LMA mucosal atomization devices

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Teleflex.

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
    Safety alert / Field Safety Notice
  • Date
    2017-04-24
  • Event Date Posted
    2017-04-24
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/lma-mucosal-atomization-devices-topical-anaesthesia-may-not-be-delivered-in-a-fully-atomised-spray
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Manufactured by teleflex – poor atomisation of the spray could result in inadequate topical anaesthesia delivery, which may lead to discomfort or difficulties delivering anaesthesia.
  • Action
    Identify and quarantine affected devices (see below). Contact Teleflex to acknowledge receipt of their field safety notice FSN Return all affected devices to Teleflex.

Device

LMA mucosal atomization devices
  • Model / Serial
  • Product Description
    See attached PDF for the affected devices.These products are used for the delivery of topical anaesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa.Note there is a separate MDA for Teleflex LMA MAD devices used to deliver medication suitable for nasal delivery, MDA/2017/XX
  • Manufacturer
    Teleflex

Manufacturer

Teleflex
  • Manufacturer Address
    Teleflex Customer Service Tel: : 01494 532761Email orders.uk@teleflex.com
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    MHRA