Table 1.

Summary of reported adverse events.

Reported adverse events	Incidence
Non-severe
Skin irritation4,5,20,21,23,25–31,36,37	Common
Allergic skin reaction5,6	Very rare
Discomfort and pain7	Common
Forefoot oedema and lymphoedemaa	Rare
Bacterial and fungal infection4,9,10	Very rare
Severe
Soft tissue damage or necrosis20–30,34–37,62	Very rare
Nerve damage31–37	Very rare
Arterial impairment24,77	Very rare
Venous thromboembolism43	Very rare
Cardiac decompensation47	Very rare

Frequency grouping: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to < 1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).⁸⁹

^aBased on experts’ experience.

Source: reproduced with permission from European Commission, 2009.⁸⁹