Events

Alerta De Seguridad para Easy Life Balloon

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Life Partners.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-03-28
  • Fecha de publicación del evento
    2014-03-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140328.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Life Partners Easy Life Balloon
  • Manufacturer
    Life Partners

Manufacturer

Life Partners