MHRA bans certain Dermapen devices

29 Aug 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has released an alert for practitioners to stop using the Dermapen 3 device, the Dermapen 3 needle tips and the Dermapen Cryo device due to potential risk of injury or infection.

The alert is relevant to products with an affected serial number/batch number, which, according to the MHRA, do not have a valid CE mark so their safety can no longer be assured.

A spokesperson from the MHRA said, “All Dermapen Cryo devices and specific serial and batch numbers of Dermapen 3 microneedling devices have been manufactured to unknown standards, therefore their safety cannot be verified and should not be used.”

Affected devices include: the Dermapen 3 device with serial numbers 3MD1605456 to 3MD1702134 inclusive, Dermapen 3 needle tips with batch numbers DP164278, DP180226 and DP180109 and all Dermapen Cryo devices.

The Dermapen microneedling devices aim to stimulate the skin for collagen production and the Dermapen Cryo devices are intended to treat skin tags, lesions, warts and benign moles.

The MHRA spokesperson advised practitioners that if they have affected devices, they should contact their supplier for further advice.

Dermapen is manufactured by Equipmed and distributed in the UK by Naturastudios. Naturastudios has confirmed that it stopped marketing the Dermapen Cryo two years ago when they decided to distribute the CryoPen instead, which they say is approved by the Food and Drug Administration and is medically CE marked.

Sales director of Naturastudios, Simon Ringer commented regarding the recent safety notice relating to the Dermapen 3 microneedling device. “As a company who works with leading brands within the aesthetics industry, we are still eagerly awaiting the Dermapen 4 to be released in the UK once it has acquired the correct classification for the UK market. This is scheduled for release early 2020. As well as this, all Dermapen needle cartridges are and have always been sterile and to date we have had no issue with any cross contamination, infection or patient reaction,” he said.

Ringer added, “As a company who prides itself on safety, training and customer service, Naturastudios has sourced the Dermapen-approved DPM8 device, which does have a CE certificate, as a contingency plan to allow our customers to carry on offering the leading microneedling treatments in conjunction with Dermapen Dermaceuticals.”

The MHRA urges practitioners to also use the Yellow Card system to report any incidents relating to the products to help build an accurate picture of the safety profile for these devices.

Comments

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  • David Banks 29 Aug 2019 / 8:11 PM

    Interesting reading I found in relation to the above on the Dermapen US Official website: https://dermapen.com/2017/04/15/dermapen-3/

    and also found the case text of the UNITED STATES DISTRICT COURT IN AND FOR THE DISTRICT OF UTAH, CENTRAL DIVISION May 9, 2017 Case No. 2:13-cv-00729-DN-EJF (D. Utah May. 9, 2017)

    .

    ..IT IS FURTHER HEREBY ORDERED that judgment shall be entered in favor of Derma Pen LLC and against 4EverYoung Limited, Biosoft (Aust) PTY LTD d/b/a Dermapenworld, Equipmed International PTY LTD d/b/a Dermapenworld, and Stene Marshall d/b/a/ Dermapenworld in the amount of $11,907,320.00.

    ...continues

  • David Banks 29 Aug 2019 / 8:17 PM

    Interesting reading I found in relation to the above on the Dermapen US Official website: https://dermapen.com/2017/04/15/dermapen-3/

    and also found the case text of the UNITED STATES DISTRICT COURT IN AND FOR THE DISTRICT OF UTAH, CENTRAL DIVISION May 9, 2017 Case No. 2:13-cv-00729-DN-EJF (D. Utah May. 9, 2017)

    .

    ..IT IS FURTHER HEREBY ORDERED that judgment shall be entered in favor of Derma Pen LLC and against 4EverYoung Limited, Biosoft (Aust) PTY LTD d/b/a Dermapenworld, Equipmed International PTY LTD d/b/a Dermapenworld, and Stene Marshall d/b/a/ Dermapenworld in the amount of $11,907,320.00.

    ...continues