Events

Field Safety Notices about BARRIER® EasyWarm®

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Mölnlycke Health Care.

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
  • Date
    2015-11-04
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Mölnlycke health care barrier® easywarm® product contains warmers to provide heat. according to a stability study the warmers have passed its intended performance for all time points except for 3,5 years, were the product did nog give sufficient amount of heat. based on this mölnlycke health care gives an advisory notice that products that are 2 years old or older should be scrapped and will be replaced free of charge by mölnlycke health care.

Device

BARRIER® EasyWarm®

Manufacturer

Mölnlycke Health Care