Events

Alerta De Seguridad para Novabel Dermal Filler

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

¿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
    2010-07-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20100802.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
    Press release
  • Causa
    Caution on novabel dermal filler the department of health (dh) has drawn public attention to reports of adverse reactions as a result of using novabel dermal filler, an implantable material for reconstruction and body contouring. dh, through its routine surveillance, found that the uk's medicines and healthcare products regulatory agency (mhra) announced that a manufacturer in germany had issued a notice to advise clinicians not to use novabel because of the dissatisfactory aesthetic outcome. the agency is assessing the adverse reactions. the affected products included all batches of novabel, dermal filler (1x1ml, art.-nr. 40800) and novabel, dermal filler (2x1ml, art.-nr. 49021). according to the manufacturer, an overall number of 70 cases of adverse reactions were reported from about 24,000 syringes sold. the reactions included redness, bruising, pain and swelling. some patients had visible and palpable nodules and indurations. many of these have resolved since being reported. while dh is obtaining more information from mhra, as precautionary measures, dh has informed healthcare professionals of hospital authority, private hospitals, and relevant medical professional associations about the alert. the spokesman said members of the public who have these reactions after using the concerned product should consult their healthcare providers. dh will monitor future developments. ends/saturday, july 31, 2010.

Device

Novabel Dermal Filler
  • Modelo / Serial
  • Descripción del producto
    Press release: Caution on Novabel Dermal Filler
  • Manufacturer
    Merz Pharmaceuticals GmbH

Manufacturer

Merz Pharmaceuticals GmbH