Events

Safety Alert for Easy Life Balloon

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Life Partners.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-03-28
  • Event Date Posted
    2014-03-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140328.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: life partners easy life balloon the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert concerning easy life balloon (reference number: elb/800-kt3.0/70 and serial numbers: all), manufactured by life partners. some users have informed the manufacturer of partial deflation cases. there may be potential complications related to a balloon deflation: partial deflation can lead to a total deflation, causing balloon migration. the balloon could remain blocked in the digestive system and cause an obstruction which could prove to be fatal for the patient. the obstruction would need to be removed, either endoscopically or surgically. the manufacturer has decided to stop marketing the affected intragastric balloon (since june 2013) and it is currently working on a solution to improve the levels of air tightness. it also recommends the followings: any remaining stock of affected products should be returned. physicians should not proceed with any new implantation of the affected products patients should be informed on all the risks and complications related with a medical device as well as the potential additional complications which are may arise. a regular monthly follow-up of patients should be performed and it is necessary for physicians to urgently meet the patients who currently have a balloon implanted in order to perform a radiological or endoscopic review of the balloon. each physician should judge the actions to be taken according to each patient: i.E. balloon to be maintained implanted, adjustment of balloon volume, or retrieval of balloon. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con394666 if you are in possession of the product, please contact your supplier for necessary actions. posted on 28 mar 2014.

Device

Easy Life Balloon
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Life Partners Easy Life Balloon
  • Manufacturer
    Life Partners

Manufacturer

Life Partners