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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 Users of the device Actions underway: 3 September 2019 Actions complete 24 September 2019 Ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation. Dermapen 3 devices are intended to stimulate the skin for natural collagen induction. Affected devices were manufactured after 30 May 2017. Dermapen Cryo devices are intended to treat skin tags, lesions, warts and benign moles. Affected serial and batch numbers are listed below: Device model name Device details Dermapen (3) device Serial numbers: 3MD1605456 to 3MD1702134 inclusive Dermapen (3) needle tips Batch numbers: DP164278, DP180226 and DP180109 Dermapen Cryo All The devices’ packaging have a CE mark but this has not been obtained through appropriate regulatory oversight. Stene Marshall Equipmed (t/a DermapenWorld Pty Ltd, Equipmed USA, Equipmed Europe Limited or Equipmed International Pty) Tel: +61 (0) 29889 3636 (Australia) Email: info@dermapenworld.com and info@equipmed.com If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.

CAS and NICAS liaison officers for onward distribution to all relevant staff including: Dentists Dermatologists Health and safety managers CAS liaison officers for onward distribution to all relevant staff including: Optometrists Hospitals in the independent sector Private medical practitioners Send enquiries about this notice to MHRA, quoting reference number MDA/2019/028 or 2019/002/027/451/001. Feza Haque, MHRA Tel: 020 3080 6000 DSS-TM@mhra.gov.uk Tel: 020 3080 7274 DCT@mhra.gov.uk To report an adverse incident involving a medical device in England use the Yellow Card reporting page. Tel: 0208 9052 3868 niaic@health-ni.gov.uk To report an adverse incident involving a medical device in Northern Ireland use the forms on the website. Alerts in Northern Ireland are distributed via the NICAS system. Tel: 0131 275 7575 nss.iric@nhs.net To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account. For more information, or if you can’t access the webform, visit the website: how to report an adverse incident. Tel: 03000 250986 or 03000 255510 Haz-Aic@wales.gsi.gov.uk To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

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