Customer notice: Response to Genuine Dermaroller safety notice
We were made aware today that a safety notice raised by Dermaroller GmbH on the 5th May 2015, and posted within the MHRA website on the 7th May, regarding specific Genuine Dermaroller medical devices models and batch / lot numbers is being circulated on social media sites and within the medical aesthetic community. Firstly we want to reassure you that no devices affected by the issues detailed in the safety notice were supplied by AesthetiCare to any UK or Irish clinics, and that we dealt with this matter back in May in accordance with ours and the Dermaroller GmbH quality systems. There are no reasons for any one to have any concerns regarding Dermaroller devices they have used or may have in stock. Dermaroller GmbH notified Bfarm – the competent authority in Germany – in May regarding the issue and their actions. Other competent authorities across Europe can then pick this up, hence the reason that the safety notice was embedded in the MHRA website on the 7th May.
Regarding the safety notice, it detailed that for some specific batches the material used in the plastic cover that protects the head of the roller within the sealed pouch was changed by the supplier without Dermaroller GmbH being notified through the necessary change control procedure, if this had occurred such a change would have been rejected. The changed material can react differently when undergoing gamma ray irradiation sterilization, potentially becoming more brittle and slightly discoloured. It can also result in the release of small quantities of hydrogen chloride, which could, over the shelf life of the device, potentially affect the needle quality. The devices involved with this issue were still sterile and the risk associated with the affected devices was low, but due to the very high quality standards employed by Dermaroller GmbH any devices affected were recalled.
We again stress that no affected devices were supplied by AesthetiCare, and for this reason, no notice was provided by us within the UK and Ireland at the time. We are notifying you now as the notice on the MHRA website has been circulated as mentioned above and we want to provide you with the necessary context to this information, and provide absolute reassurance. This can also provide you with confidence that we follow medical device vigilance and provide a high level of safety assurance and control, and this is one of the great reasons to use a high quality medical device, and in particular the Genuine Dermaroller.
If you have any questions, please don’t hesitate to contact us.