Report provided by the end user states that itching is occuring under the mass, directly next to the stoma.There does not appear to be any leaking or irritation to the skin.The end user uses warm water, a paper towel to dry, an ostomy powder, skin prep and then the seal.Skin care was reviewed with the end user, discussed alcohol free wipes and convexity.Samples of alternate products are being sent.The end user subsequent outcome was not reported.
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Convatec is submitting this report as a result of remediation activities related to the fda 483 issues april 16, 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report, shall be filed on a supplemental mdr.Analysis is taken from a trending report of evaluations or adverse events finalized (b)(4) 2011.The data presented is from (b)(4) different product applications.The report states that there are no significant trends.
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