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Medical Device Alert: Novabel® dermal filler manufactured by Merz Pharmaceuticals GmbH (MDA/2010/064)

Document details:

Type: Medical Device Alert
Series No: MDA/2010/064
Audience: Healthcare professionals
Published: 12 August 2010 at 12:00
Format: Electronic only
Size: A4
Pages: 5
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Immediate action

Ref: MDA/2010/064 | Issued: 12 August 2010 at 12:00

  1. England
  2. Northern Ireland
  3. Scotland
  4. Wales
  5. Device
  6. Problem
  7. Action
  8. Distribution
  9. Manufacturer
  10. Feedback

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/064 or 2010/007/023/081/016.

Technical aspects
Miss Feza Haque or Mr Ian Smith
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3066 / 3306
Fax: 020 7084 3106

Email: feza.haque@mhra.gsi.gov.uk and ian.smith@mhra.gsi.gov.uk 

Clinical aspects
Dr Nicola Lennard
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3126
Fax: 020 7084 3111

Email: nicola.lennard@mhra.gsi.gov.uk 

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Novabel® dermal filler.

Manufactured by Merz Pharmaceuticals GmbH.

1x1 ml, Art.-Nr. 40800 and 2x1ml, Art.-Nr. 49021.

All batches.

Novabel® is a colourless dermal filler composed of cross-linked alginate. It is supplied in a prefilled, 1 ml, single-use syringe with two sterile 30G ½ needles.

Use of Novabel® dermal filler may cause adverse reactions.

Merz Pharmaceuticals GmbH issued a Field Safety Notice (dated 23 July 2010), advising practitioners to stop using Novabel®.

The manufacturer has received reports of adverse reactions to the filler including redness, bruising, pain, swelling and histologically confirmed granuloma. They have also received reports of nodules and indurations in the infra-orbital area.

  • Do not use Novabel® dermal filler.
  • Return all unused product to Merz Pharma UK Ltd.
  • Monitor patients who have received Novabel® and in particular those who exhibit symptoms linked to the use of Novabel®.

 

  • If you administer Novabel®:
    • cease use of the product
    • return unused syringes to Merz Pharma UK Ltd.
    • following application, patients should have been advised to return and seek treatment in case of progressive adverse reactions including redness, bruising, pain, swelling, nodules, indurations and granuloma
    • follow up patients who exhibit residual adverse symptoms (described above) three months after application
    • where symptoms persist, consider referring patients to a plastic surgeon for further treatment.

 

  • If you are a plastic surgeon:
    • if a patient presents with symptoms linked to Novabel® use, consider the need to treat with minocycline or injectable steroids.

This MDA has been distributed to:

  • NHS trusts in England (Chief Executives)
  • HSC trusts in Northern Ireland (Chief Executives)
  • NHS boards in Scotland (Chief Executives)
  • NHS boards and trusts in Wales (Chief Executives)
  • Primary care trusts in England (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • Clinical governance leads
  • Day surgery units
  • Dental departments
  • Dental nurses
  • Dentists
  • General surgical units, directors of
  • Health and safety managers
  • Medical directors
  • Nursing executive directors
  • Ophthalmic nurses
  • Ophthalmologists
  • Ophthalmology departments
  • Ophthalmology, directors of
  • Outpatient clinics
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Pharmacists
  • Purchasing managers
  • Supplies managers

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

  • Clinics
  • Hospitals in the independent sector
  • Independent treatment centres
  • Nursing agencies
  • Private medical practitioners

Health Protection Agency to:
Directors for onward distribution to:

  • Divisional directors
  • Heads of department
  • Heads of health, safety and quality
  • Health protection nurses
  • Risk manager
  • Safety officers

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

  • Community dental practices
  • Community hospitals
  • Community nurses
  • Community pharmacists
  • Directors of public health
  • General dental practitioners
  • General practitioners
  • NHS walk-in centres
  • Practice nurses

Medical Information Department
Merz Pharma UK Ltd
260 Centennial Park
Elstree Hill South
Elstree
Herts
WD6 3SR

Tel: 020 8236 0000
Fax: 020 8236 3501

Email: medical.information@merz.com

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk
Page last modified: 12 August 2010