Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence, should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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As reported though not verified, the patients skin still showing strong skin irritation.This consumer got a colostoma on (b)(6) 2015, since than he has used the base plate together with brava paste and brava barrier spray.His skin has shown strong redness, which is weeping, itching and aching located in the area of the base plate.The patient has consulted a physician who has done an allergie-test, which has shown the patient is allergic to 1,3-diphenylguanidine.Furthermore a small wound, which is producing yellow-green secretion, existing beside the stoma.The physician has prescribed cortisone salve to treat the skin irritation.The skin became better, redness still existing, but not weeping and new epithelial tissue has grown in places.
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