Alerta De Seguridad para Restylane SubQ Lidocaine 2ml dermal filler

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

¿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
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Press release
  • Causa
    Recall of restylane subq lidocaine 2ml dermal filler the department of health (dh) today (february 21) drew public attention to the recall of a dermal filler, restylane subq lidocaine 2ml (batch numbers: 11907 and 11516), due to defects in the sealing of the package which might compromise the external sterility of syringes containing the product. the dh received notification from the product's local supplier, galderma hong kong limited, that the swedish manufacturer, q-med ab, had initiated a recall of the above product. "according to the manufacturer, the decision to recall the affected products from the market is due to defects in the sealing of the package. while the sterility of the content inside the syringe is unaffected, defects in the package mean that the external sterility of the syringe can no longer be guaranteed," a dh spokesperson explained. "further investigation into the local supplier's product distribution records shows that it has distributed the affected products, comprising about 170 pieces, to medical clinics and beauty centres from june 2012 to february 2013," the spokesperson added. so far, the dh has not received any adverse event reports related to the products. the dh will closely monitor the recall. in case members of the public have the products in their possession, they can contact galderma on its hotline (2238 0900) for public enquiries. the spokesperson also reminded the public that anyone who is in doubt or feeling unwell after having used the product should consult health-care professionals. the dh has informed public and private hospitals and relevant medical associations about the issue. ends.


  • Modelo / Serial
  • Descripción del producto
    Press release: Recall of Restylane SubQ Lidocaine 2ml dermal filler
  • Manufacturer