Events

Avis De Sécurité sur Micro-Needling devices and Needle Cartridges

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2017(23)
  • Date
    2017-06-27
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    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 / Alertes
    "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."
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Micro-Needling devices and Needle Cartridges Priority 2 – Warning
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA