Events

Alerta De Seguridad para teosyal products

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

¿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
    2014-06-19
  • Fecha de publicación del evento
    2014-06-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140619.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: teoxane teosyal products the health canada posted a medical device safety alert concerning teosyal, teosyal meso, teosyal kiss, teosyal first lines, teosyal ultra deep, teosyal ultimate, teosyal puresense ultra deep, teosyal puresense kiss, teosyal puresense deep lines, teosyal puresense global action, teosyal puresense first lines, teosyal puresense redensity i and teosyal puresense redensity ii, manufactured by teoxane. according to the alert, a 48-year-old female experienced an anaphylactic collapse with low blood pressure after injection of hyaluronic acid dermal filler with lidocaine. in response to the incident, the manufacturer will update the instructions for use as follows: the first change, applicable to all teosyal products, is the addition of a sentence related to the risks of anaphylactic shock in the side effects paragraph. the second change concerns only teosyal ultra deep and teosyal puresense ultra deep and deals with a modification of the injection depth. for further details, please refer to health canada website http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/40073r-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 19 jun 2014.

Device

teosyal products
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Teoxane Teosyal products
  • Manufacturer
    Teoxane

Manufacturer

Teoxane