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YellowCard
Making medicines and medical devices safer

Case study: Skin wipes

Background information

We received some Yellow Card reports from patients having adverse reactions after touching equipment or surfaces that had been cleaned with Clinel wipes. These reactions varied from skin reactions such as a rash, to anaphylaxis. 

Investigation

We looked into the ingredients and worked with the manufacturer to find a possible cause for these reactions. It seemed that after using the wipes on equipment throughout the day, not enough time was left for them to dry. 

Response

Working with the manufacturer, the instructions for use were updated and a Field Safety Notice (FSN) was produced. It highlighted that enough time should be allowed for cleaned equipment to dry. 

Result

The reports of allergic reactions over the last 10 months have reduced. 

Important Information

Anaphylaxis is a severe, potentially life-threatening allergic reaction that can develop rapidly. It is also known as anaphylactic shock. Signs of anaphylaxis include: itchy skin or a raised, red skin rash. swollen eyes, lips, hands and feet.

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