Events

Notificaciones De Seguridad De Campo acerca de Micro-Needling devices and Needle Cartridges

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por N/A.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2017(23)
  • Fecha
    2017-06-27
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/micro-needling-devices-and-needle-cartridges-priority-2-warning&id=ab1e0826-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    It has come to the attention of the hpra that micro-needling devices manufactured by dermapenworld and needle cartridges manufactured by sunwoo are being ce marked under medical devices legislation and placed on the irish market. the hpra has been unable to confirm that either sunwoo or dermapenworld have the appropriate certification to support ce marking for these devices. the safety, performance and quality of products which are not appropriately certified cannot be assured. the hpra is issuing this notice to alert users, in particular cosmetic clinics, to check existing stock and contact their suppliers as necessary.
  • Acción
    The HPRA advises that users: Examine stock for Micro-Needling devices and Needle Cartridges manufactured by SUNWOO or Dermapenworld. Take appropriate action, for example consider the need for quarantine and / or return of affected product. Where in doubt, contact your supplier to request valid certification for your device. A valid medical device certificate should be issued by a designated Notified Body, be in date, bear the name of the device manufacturer (as named on the device labelling), and devices covered. The HPRA would also like to emphasise that non-CE marked Micro-Needling devices should not be used for medical purposes. This includes therapeutic treatments (e.g. for disease / injury / acne) and transdermal delivery of substances to the body.

Device

Micro-Needling devices and Needle Cartridges
  • Modelo / Serial
  • Descripción del producto
    Micro-Needling devices and Needle Cartridges Priority 2 – Warning
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA