Alerte De Sécurité sur Easy Life Balloon

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Life Partners.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-03-28
  • Date de publication de l'événement
    2014-03-28
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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

  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Life Partners Easy Life Balloon
  • Manufacturer

Manufacturer