Events

Alerta De Seguridad para Hyaluronic acid-based implants

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Teoxane S.A..

¿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
  • ID del evento
    R1605-220
  • Número del evento
    2012DM-0009198
  • Fecha
    2016-05-25
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=139
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer informs that it has detected that the expiration date of the needles expires three to seven months before the expiration indicated in the box of the syringes, although it does not imply a risk of its use, it has been determined to withdraw the specific product since the sterility of the syringes can not be guaranteed. the needles beyond their expiration date, leading to potential adverse events for patients.

Device

Hyaluronic acid-based implants
  • Modelo / Serial
    TEOSYAL ULTIMATE, TEOSYAL PURESENSE ULTIMATE, lots TST-142103, TSTL-143902 and TSTL-154704.
  • Descripción del producto
    Hyaluronic acid-based implants containing 3% lidocaine hydrochloride. They are indicated for the filling of the wrinkles and lines, increase the volume of the lips and reshape the facial contour, reducing the slight pain in the injection site.
  • Manufacturer
    Teoxane S.A.

Manufacturer

Teoxane S.A.
  • Empresa matriz del fabricante (2017)
    Teoxane S.A.
  • Source
    NIDFSINVIMA