The end user reports, while open to the air for 2 hours, reddened skin the under the mass area in a uniform, solid area.No open skin.The redness gets better in the 2 hours, but does not go away completely.Discussed using a protective barrier under the mass as well.The end users 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 issued 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 analysis is taken from a trending report of evaluations or adverse events finalized (b)(6) 2011.The data presented is from three different product applications.The report states that there are no significant trends.
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