The Government’s Medicines and Healthcare Products Regulatory Agency (MHRA) had issued a warning about the use of a Microneedling pen – warning of possible injury or infection from them.
For information, the pens in question are Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips for: Dermapen 3.
They are manufactured by Equipmed and other trading names and distributed in the UK by Naturastudios.
The advice from the MHRA is: “Do not use affected devices as they have been manufactured to unknown standards and their safety cannot be verified”.
The MHRA website says:
“Identify and do not use any affected devices in your possession.
“Circulate this medical device alert within your organisation and ensure all device users are aware they should stop using these devices.
“Contact manufacturer/distributor for further advice.
“Report suspected or adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: Yellow Card Scheme in England or the appropriate authority in Scotland, Northern Ireland and Wales.”
The devices’ packaging have a CE mark but this has not been obtained through appropriate regulatory oversight.
For any more information see the MHRA website notification via: