Action

Identify if you have any devices from the affected lots listed in the manufacturer’s FSN.

Contact ConvaTec to arrange return of affected devices and replacements, free of charge.

Share this information with all those who may also have affected product, including patients.

Complete the ‘End User Response Form’ in the FSN even if you don’t have affected devices left in stock, and return it to tracey.fairclough@amcaregroup.co.uk

Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Action by

Healthcare professionals and users of the device.

Deadlines for actions

Actions underway: 30 January 2020

Actions complete: 13 February 2020

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.

Remember

If your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.

Device details

SurFit™/ Combihesive™ Wafers, manufactured from February 2017 to September 2018:

System 92 Secure Moldable Convex Durahesive™ Wafer

System 92 Secure Durahesive Wafer with Convex

Problem / background

A number of these devices have been produced with an off-centre starter hole as shown in Figure 1 (shown in attachment).

The manufacturer of the device is Convatec.

Distributors, retailers and wholesalers should contact: Stericycle

Phone: 0800 069 8202

Email: Convatec2p@stericycle.com

Patients should contact: Tracey Fairclough

Phone: 07442 188 256

Email: tracey.fairclough@amcaregroup.co.uk

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:

Adult intensive care units

Community children’s nurses

Community hospitals

Community nurses

District nurses

Equipment stores

Gastroenterology departments

Gastroenterology, directors of

Gastro-intestinal surgeons

General surgery

Hospital at home units

Hospital pharmacies

Hospital pharmacists

Intensive care medical staff/paediatrics

Intensive care nursing staff (adult)

Intensive care nursing staff (paediatric)

Intensive care units

Oncology nurse specialists

Outpatient clinics

Outpatient theatre managers

Outpatient theatre nurses

Paediatric intensive care units

Paediatric medicine, directors of

Paediatric nurse specialists

Paediatric oncologists

Palliative care teams

Pharmacists

Purchasing managers

Renal medicine departments

Renal medicine, directors of

Urological surgeons

Urological surgery, directors of

Urology departments

GP Practices registered with CAS

This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.

NHS England area teams

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

Community pharmacists

GP practices not yet registered with CAS (for information only)

This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.

Social services

Liaison officers for onward distribution to all relevant staff including:

Care at home staff

Care management team managers

Children’s disability services

Community care staff

Equipment stores

Equipment supplies managers

In-house domiciliary care providers (personal care services in the home)

In-house residential care homes

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

Adult placement

Care homes providing nursing care (adults)

Care homes providing personal care (adults)

Domiciliary care providers

Hospices

Hospitals in the independent sector

Independent treatment centres

Please note

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: safetyalerts@mhra.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2020/002 or 2019/008/028/701/002.

Technical aspects

Eliz Mustafa or Emma Rooke, MHRA



Tel: 020 3080 6000

Email: DSS-TM@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA



Tel: 020 3080 7274

Email: dct@mhra.gov.uk

To report an adverse incident involving a medical device in England use the Yellow Card reporting page.

Northern Ireland

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health (Northern Ireland)



Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

https://www.health-ni.gov.uk/niaic

To report an adverse incident involving a medical device in Northern Ireland use the forms on our website.

Alerts in Northern Ireland are distributed via the NICAS system.

Scotland

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

Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services Scotland



Tel: 0131 275 7575

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

To report an adverse incident involving a medical device in Scotland, email nss.iric@nhs.net 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

Enquiries in Wales should be addressed to:

Population Healthcare Division, Welsh Government



Tel: 03000 255278 / 03000 255510

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

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download documents

Convex two-piece skin barriers (Natura /Surfit /Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier (MDA/2020/002)