Safety Notice

Medical Devices

Head Lice Treatment Products –Risk of Fire

Priority 2 – Warning

HPRA Safety Notice: SN2018(08) Issue Date: 07 February 2018

SUR-F0017-4 1/2

MANUFACTURER / SUPPLIER

HPRA CASE REFERENCE

Various manufacturers

V34570

ISSUE

The HPRA wishes to raise awareness of the risk of fire associated with some head lice treatment products which are available in Ireland.

Exposure to a naked flame, any heat source or smoking during use of some head lice treatment products could cause serious injury.

ACTION OR RECOMMENDATIONS

The HPRA advises that users:

1. Read the information provided with the product prior to use.

2. Ensure you are aware of all warnings on these products.

3. Keep away from naked flames, sources of heat and do not smoke when using these products.

4. Please pass this notice on to all those who need to be aware within your organisation and to any organisation/persons where these products are used.

5. Report any adverse events/incidents associated with these products to the relevant manufacturer and the HPRA.

MANUFACTURER / SUPPLIER: Various manufacturers

HPRA CASE REFERENCE: V34570

Issue :

The HPRA wishes to raise awareness of the risk of fire associated with some head lice treatment products which are available in Ireland. Exposure to a naked flame, any heat source or smoking during use of some head lice treatment products could cause serious injury

Actions and or Recommendations

The HPRA advises that users:

1. Read the information provided with the product prior to use.

2. Ensure you are aware of all warnings on these products.

3. Keep away from naked flames, sources of heat and do not smoke when using these products.

4. Please pass this notice on to all those who need to be aware within your organisation and to any organisation/persons where these products are used.

5. Report any adverse events/incidents associated with these products to the relevant manufacturer and the HPRA.

TARGET GROUPS

A&E Departments Carers

Community Pharmacists Dermatology Units General Practitioners Hospital Managers / CEOs Hospital Pharmacists

Members of the Public Nursing Managers Nursing Staff Purchasing Managers Risk Managers Schools

BACKGROUND

The HPRA is aware of serious incidents relating to the use of certain head lice treatment products and is concerned that there may be a lack of awareness of the risk of fire associated with certain products.

Parents, carers and all users are advised to carefully read the information provided with the product and the associated warnings prior to use, and to only use the product as recommended.

The HPRA is issuing this safety notice to raise awareness of the risk of fire associated with some head lice treatment products.

MANUFACTURER CONTACT INFORMATION

Enquiries to the manufacturer should be addressed to the contact details found on the device labelling / instructions for use.

HPRA CONTACT INFORMATION

All adverse incidents relating to a medical device should be reported to:

Health Products Regulatory Authority Telephone: +353-1-6764971 Kevin O’Malley House Fax: +353-1-6344033 Earlsfort Centre E-mail: devicesafety@hpra.ie Earlsfort Terrace Website: www.hpra.ie

Dublin 2