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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: firstname.lastname@example.org and email@example.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:
Health and safety managers
CAS liaison officers for onward distribution to all relevant staff including:
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
Tel: 020 3080 7274
To report an adverse incident involving a medical device in England use the Yellow Card reporting page.
Tel: 0208 9052 3868
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
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
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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