Events

Field Safety Notices about Micro-Needling devices and Needle Cartridges

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by N/A.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2017(23)
  • Date
    2017-06-27
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    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
  • Notes / Alerts
    "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."
  • Extra notes in the data
  • Reason
    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.
  • Action
    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
  • Model / Serial
  • Product Description
    Micro-Needling devices and Needle Cartridges Priority 2 – Warning
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA