Regulatory information

Regulatory information

Coban 2 was CE marked as a class I medical device in 2007.

The FDA database of adverse events (MAUDE) has 5 reports for adverse events associated with Coban 2 since January 2000. Two of these were in people with venous leg ulcers:

  • A person with deep vein thrombosis with venous stasis ulcer. After treatment with Coban 2 there was ulceration on the tendon, needing surgery.

  • A person with a venous leg ulcer and a non-traumatic injury on the lower left leg. After treatment with Coban 2, a necrotic lesion was noted measuring 4 cm x 3.5 cm with a depth of 0.3 cm. The lesion was over the left ankle and there was an exposed tendon.

No adverse events were found following a search of the Medicines and Healthcare products Regulatory Agency website. However, a Coban 2 Field Safety Notice from 2016 addresses an error in the print on the Coban 2 packaging.