Microneedling pens: Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips for: Dermapen 3 – risk of injury or infection (MDA/2019/028)
Manufactured by Equipmed and other trading names (listed in the ‘Manufacturer contacts’ section), distributed in the UK by Naturastudios. Do not use affected devices as they have been manufactured to unknown standards and their safety cannot be verified.
Action
- 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
Action by
Users of the device
Deadlines for actions
Actions underway: 3 September 2019
Actions complete 24 September 2019
Medical Device Safety Officers (in England)
Ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Device details
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 |
Problem/background
The devices’ packaging have a CE mark but this has not been obtained through appropriate regulatory oversight.
Manufacturer contacts
Stene Marshall Equipmed (t/a DermapenWorld Pty Ltd, Equipmed USA, Equipmed Europe Limited or Equipmed International Pty) Tel: +61 (0) 29889 3636 (Australia) Email: [email protected] and [email protected]
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- Dentists
- Dermatologists
- Health and safety managers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- Optometrists
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Private medical practitioners
Please note CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: [email protected] and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/028 or 2019/002/027/451/001.
Technical aspects
Feza Haque, MHRA Tel: 020 3080 6000
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
To report an adverse incident involving a medical device in England use the Yellow Card reporting page.
Northern Ireland
Northern Ireland Adverse Incident Centre (NIAIC)
CMO Group
Department of Health, Social Services and Public Safety
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.
Scotland
Incident Reporting and Investigation Centre (IRIC)
Health Facilities Scotland
NHS National Services Scotland
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.
Wales
Population Healthcare Division, Welsh Government
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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