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Scholl Freeze Verruca and Wart Remover
Notice type:
Warning
Date:
27/07/2007
Product name or type:
Scholl Freeze Verruca and Wart Remover
Reference:
SN2007(03)
Manufacturer Or Supplier:
SSL International plc., United Kingdom.
Target Audience:
General Public; Pharmacists; General Practitioners; Healthcare Professionals; Nurses; Health Service Executive (HSE)
Problem Or Issue:
The risk of severe freeze burns after use of Scholl Freeze Verruca and Wart Remover.
Background Information Or Related Documents:
The Irish Medicines Board (IMB) is aware of incidents where consumers received severe freeze burns after using Scholl Freeze Verruca and Wart Remover. The investigation carried out by the manufacturer indicates possible misuse of the product as the root cause, whereby spraying the product directly onto the verruca / wart, as opposed to application via the applicator bud, can lead to damage of healthy skin surrounding the verruca / wart.
The product carton and the instructions for use (IFU) have since been revised to further reinforce warnings on the incorrect application of the product to the affected verruca / wart.
Scholl Freeze Verruca and Wart Remover Document
Actions To Be Taken:
For your information to be aware of these changes
Ensure all product contains new IFU and product livery
Please ensure that the IFU are adhered to. In particular, the instruction for the correct application of the product
Further Information:
All adverse incidents relating to a medical device should be reported to the:
Health Products Regulatory Authority
Medical Devices Department
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
If you have any enquiries, you may contact the Medical Devices Department at:
Telephone: +353-1-6764971
Fax: +353-1-6344033
Email:
vigilance@imb.ie
Website:
www.hpra.ie
Enquiries to the manufacturer should be addressed to:
SSL International plc.
Venus 1
Old Park Lane
Trafford Park
Urmston
Manchester M41 7HA
United Kingdom
Contact: Ms. Lisa Caton (Consumer Relations Manager)
Telephone: +44-870-122-2690
Fax: +44-161-615-8814
Email:
consumer.relations@ssl-international.com
SN2007(03): Scholl Freeze Verruca and Wart Remover
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Date Printed: 25/04/2024